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In a trial in resected stage III mismatch repair–deficient colon cancer, adding atezolizumab to modified FOLFOX6 improved 3-year disease-free survival, with a higher incidence of grade 3 or 4 toxic effects, mainly fatigue.

In this study, gene editing with a prime editor was used to treat two persons with chronic granulomatous disease caused by a small deletion in the gene NCF1.

Corporations that make and market health-harming products are a primary vector for the global increase in mortality related to noncommunicable diseases. Research using internal industry documents can help.

In countries with organized screening programs for colorectal cancer, 25% of patients who receive a diagnosis have stage III disease with involved regional lymph nodes. Surgery cures only half these patients, and 6 months of fluoropyrimidine-based adjuvant chemotherapy (e.g., intravenous fluorouracil or oral capecitabine) has been the cornerstone of treatment...

Immunodeficiency chronic granulomatous disease (CGD) is a rare disorder characterized by defects in a multiprotein complex that generates superoxide in phagocytic cells.1 Recurrent infections and formation of granulomas are hallmarks of X-linked and autosomal-recessive CGD, which is caused by variants in genes encoding individual subunits. As a monogenic...

A 12-year-old girl was admitted to the hospital with altered mental status and abdominal distention. The blood glucose level was 30 mg per deciliter. Symptoms abated with glucose administration. A diagnosis was made.

In an evaluation in low- and middle-income countries involving 95 patients with chronic myeloid leukemia who had deep remission for more than 1 year, 79% remained in treatment-free remission after imatinib discontinuation.

Among men with locally advanced prostate cancer, transdermal estradiol was noninferior to LHRH agonists for 3-year metastasis-free survival and led to a lower incidence of hot flashes but a higher incidence of gynecomastia.

In a phase 1 trial of setidegrasib, a KRAS G12D degrader, 42% of patients had adverse events of grade 3 or higher; 36% of patients with NSCLC and 24% of those with pancreatic cancer had a response.

The Trump administration’s wide-ranging actions to dismantle U.S. environmental regulations will cause long-lasting health harms, disproportionately affecting low-income and other vulnerable groups.

Among patients with traumatic hemorrhage, prehospital whole-blood transfusion was not superior to standard transfusion with red-cell and plasma components in reducing the risk of death or massive transfusion.

In a phase 3 trial in patients with persistent chemotherapy-induced thrombocytopenia, 84% of those receiving romiplostim had no chemotherapy dose modifications, as compared with 36% of those receiving placebo (odds ratio, 10.16).

In untreated chronic lymphocytic leukemia, fixed-duration venetoclax-based regimens were noninferior to continuous ibrutinib with regard to 3-year progression-free survival and were associated with higher MRD-negative rates.

The IARC Working Group summarizes guidance on H. pylori screen-and-treat programs for gastric cancer prevention and concludes that prevention is the most effective strategy amid a rising global burden.

The CMS Innovation Center is approaching the next negotiation cycle for the CGT Access Model. Several considerations will guide the selection of future candidate diseases and potential new model designs.

Myelosuppression has long been the major dose-limiting toxic effect of chemotherapy in treating cancer. Reducing the severity of chemotherapy-induced myelosuppression addresses two priorities. One is to prevent myelosuppressive complications — neutropenia and thrombocytopenia, in particular — that can lead to febrile neutropenia, infection, and bleeding. A second priority centers around...

A 49-year-old woman presented with a 6-month history of an itchy lump on her vulva. Examination showed a painless purple mass originating in the labia minora on the left side.

Neoadjuvant gemcitabine–oxaliplatin, lenvatinib, and anti–PD-1 antibody led to longer event-free survival than surgery alone in resectable high-risk intrahepatic cholangiocarcinoma, with mainly low-grade adverse events.

This review summarizes advances in radiotherapy that reduce injury to normal tissue, including improvements in the precision of imaging and delivery, and outlines strategies to prevent and manage treatment-related side effects.

A CD19-targeted therapy induced remission in a woman with refractory immune thrombocytopenia and antiphospholipid syndrome by stabilizing platelet counts, eliminating pathogenic antibodies, and enabling safer long-term anticoagulation.

On Feb 4, 2026—World Cancer Day—the long-overdue National Cancer Plan for England was finally published. The plan sets ambitious targets, promising that three quarters of all patients diagnosed with cancer will survive at least 5 years and that the UK will become a global leader in cancer survival by 2035. However, the feasibility of these ambitions is doubtful. The UK's current 5-year survival is among the lowest of all high-income countries, and internal reviews have presented the National Health Service (NHS) as broken.

The Lancet Oncology Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) study on global breast cancer burden provides comprehensive epidemiological trends from 1990 to 2023, with projections to 2050.1 According to this study, breast cancer was the most diagnosed cancer up until 2023.2 Although this ambitious undertaking addresses crucial needs in global oncology, several methodological concerns warrant attention before these estimates inform policy decisions and resource allocation.

The therapeutic landscape of early-stage HER2-positive breast cancer has been transformed over the past two decades.1 The introduction of HER2-directed therapy, including the antibody trastuzumab, has fundamentally altered the natural history of this disease, converting an aggressive breast cancer subtype associated with poor outcomes into one with high rates of pathological complete response and excellent long-term survival.1,2 These gains were initially achieved using intensive multi-agent regimens incorporating HER2-directed therapies with anthracyclines, taxanes, and platinum chemotherapy in both the adjuvant and neoadjuvant settings.

Metastatic uveal melanoma is a rare and life-threatening cancer with limited treatment options. A characteristic feature of uveal melanoma is its strong liver tropism, resulting in liver metastases in approximately 90% of patients who develop metastatic disease. This distinct pattern has led to investigations of liver-directed therapeutic strategies in patients with uveal melanoma.

Timo F W Soeterik and colleagues1 are to be congratulated for their important contribution to guiding personalised treatment in patients with oligorecurrent prostate cancer, published in The Lancet Oncology. In this multicentre retrospective analysis, the authors curated a cohort of more than 500 men with metachronous oligometastatic prostate cancer who underwent prostate-specific membrane antigen (PSMA) PET for disease characterisation, followed by ablative radiotherapy to all sites of oligometastases.

20 years ago, the combination of radiotherapy with concomitant and adjuvant temozolomide, also known as the Stupp protocol,1 transformed glioblastoma treatment. It was the first multimodal regimen to show a survival advantage in newly diagnosed glioblastoma and is the standard of care two decades later. The trial1 identified a biomarker (MGMT) to predict benefit from temozolomide; yet this represents only the beginning of what biologically informed patient selection could achieve. Advances in single-cell profiling, spatial imaging, and systems immunology are revealing fundamental determinants of glioblastoma behaviour, including dynamic cell states, lineage plasticity, metabolic constraints, and the role of the brain's resident and infiltrating immune cells.

In December, 2025, the Trump administration announced completion of the second cycle of historic price negotiations between US Medicare and pharmaceutical manufacturers.1 Concurrently, it released plans to establish international reference pricing to lower the costs of cancer drugs and other medicines in Medicare to levels in peer countries.2 These policy changes could have important effects on access to cancer medicines globally.

I appreciate the excellent work by Natólia Alves and colleagues,1 comparing artificial intelligence (AI) and radiologists in pancreatic cancer detection using standard of care CT scans (PANORAMA study). The paper is a milestone in evaluating the real-world diagnostic performance of an AI system for the detection of pancreatic ductal adenocarcinoma (PDAC) on contrast-enhanced CT. This important advance will facilitate PDAC surveillance of individuals who are at high risk.2 However, PANORAMA study's AI system1 is not suitable for PDAC screening of people who are at average risk of PDAC and are asymptomatic.

We thank Hans Scherübl and Misha D P Luyer1 for their insightful comments on the PANORAMA study,2 regarding the challenges and opportunities of artificial intelligence (AI)-assisted detection of pancreatic ductal adenocarcinoma (PDAC), particularly in early-stage disease.

We congratulate Huiping Li and colleagues on the FABULOUS trial,1 which establishes fuzuloparib, with or without apatinib, as a viable option for HER2-negative metastatic breast cancer with germline BRCA1/2 mutations. As clinicians practising in a prefecture-level hospital in the Hunan province, we consider these findings from the perspective of accessibility and real-world applicability in resource-constrained settings.

We thank Ziran Qiu and Na Jin for their Correspondence regarding the FABULOUS trial1 and appreciate their practical perspectives.

We read with great interest the phase 2 KUNPENG trial by Yi-Long Wu and colleagues.1 The reported objective response rate of 48·8% with vebreltinib in MET amplification-driven non-small-cell lung cancer is promising. However, the use of a gene copy number (GCN) of six or higher as the sole enrolment criterion obscures crucial biological heterogeneity within this population. This methodological choice fundamentally limits the interpretability of the efficacy signal and poses a considerable risk for the design of the planned phase 3 trial.

We thank Yuxin Liu and colleagues for their interest in the KUNPENG study and concur that a clinically meaningful MET amplification cutoff is crucial to trial design and interpretation.1 Indeed, our selection of a gene copy number (GCN) of six or higher assessed by fluorescence in-situ hybridisation (FISH) was grounded in a biological rationale and clinical precedent. Mechanistically, MET amplification promotes oncogenesis through GCN gain-induced MET protein phosphorylation, and a GCN of six or higher confers a potent oncogenic driver function independent of hepatocyte growth factor.

The National Health Service (NHS) in England, UK, has set up the world's first national genetic cancer risk register to help track and screen individuals at higher risk of developing cancer and offer preventive and personalised care.

Lithuania has now joined a growing list of more than 100 countries worldwide that have introduced a tax on sugar-sweetened beverages (SSBs). The tax, introduced from Jan 1, 2026, means the Baltic nation is one of many countries using fiscal policies to help encourage healthier diets across its population. Lithuania will also be taxing artificially sweetened beverages.

On Jan 27, 2026, India and the EU announced the conclusion of a comprehensive free trade agreement (FTA) as part of the 16th EU–India Summit, held in New Delhi, India. The new agreement creates a free trade zone affecting more than 2 billion people by eliminating or reducing tariffs on chemical inputs, medical devices, and pharmaceuticals, including cancer drugs.

On Jan 27, 2026, Zimbabwe's Medicines Control Authority (MCAZ) alerted citizens about the circulation of an unauthorised formulation of goserelin acetate, a hormone therapy used in the treatment of prostate and breast cancer. It warned that the product could pose risks to patient safety. “Our records show that this product was not formally imported into Zimbabwe. The MCAZ cannot therefore ascertain the safety, quality and efficacy of this product”, the alert read.

The UK National Health Service (NHS) will meet all three core cancer standards by 2029, according to a new National Cancer Plan for England, published on Feb 4, 2026. This is despite national treatment targets having not been hit for more than a decade.

A coalition of 13 Democratic state attorney generals is urging the Trump administration to drop a “dangerous and scientifically unsupported” revision to a federal formaldehyde-inhalation risk assessment they say would put workers, consumers, and communities at risk of formaldehyde-linked cancers and asthma.

On Feb 4, 2026, Health Minister Stéphanie Rist announced that the French Government will launch a targeted lung cancer screening trial in March, 2026, with the aim of making screening systematic by 2030.

The US Food and Drug Administration (FDA) has fast-tracked a promising new gene therapy, KB707, which is inhaled as a fine mist for the targeted treatment of advanced or metastatic non-small-cell lung cancer.

The Musée Curie, nestled in the historic heart of Paris near the Panthéon, offers a compelling journey through the extraordinary legacy of Marie and Pierre Curie—pioneers whose groundbreaking work in radioactivity transformed both science and medicine. As a dedicated centre for preserving and showcasing their contributions, the museum provides invaluable insights into the origins of radiological research and its profound impact on modern cancer therapies.

Earthquakes constitute major natural hazards, with the potential to cause extensive damage to infrastructure, substantial loss of life, and economic consequences. Türkiye is situated at the intersection of the Arabian and Eurasian tectonic plates and is traversed by both the North Anatolian and East Anatolian fault lines, resulting in high seismic activity across the region. In the last century, the country has experienced 16 major earthquakes with magnitudes of Mw 7·0 or higher. Among these earthquakes were the two major seismic events of 2023 (Mw 7·7 and Mw 7·6), which profoundly impacted southeastern Türkiye and northern Syria, resulting in more than 50 000 deaths and widespread structural destruction, including critical damage to health care facilities.

This 10-year follow-up confirms the non-inferiority of the ultra-hypofractionated radiotherapy regimen compared with the conventionally fractionated, with similar toxicity profiles. The findings support the seven-fraction schedule as a safe, effective, and practical standard-of-care option for patients with intermediate-risk prostate cancer.

The stable incidence and declining mortality rates of female breast cancer in high-income nations reflect success in screening, diagnosis, and treatment. In contrast, the concurrent rise in incidence and mortality in other regions signals health system deficits. Without effective interventions, many countries will fall short of the WHO Global Breast Cancer Initiative's ambitious target of achieving an annual reduction of 2·5% in age-standardised mortality rates by 2040. The mounting breast cancer burden, disproportionately affecting some of the world's most vulnerable populations, will further exacerbate health inequalities across the globe without decisive immediate action.

Vibostolimab coformulated with pembrolizumab did not provide additional clinical benefit versus pembrolizumab as adjuvant therapy in participants with resected stage IIB–IV melanoma. Pembrolizumab monotherapy remains a standard of care for resected high-risk melanoma.

Global access to brachytherapy remains profoundly unequal, with adequate coverage largely limited to HICs. Resource gaps are greatest in lower-income settings, where patients also travel farthest. Investment in new centres is urgently needed to reduce geographical and economic barriers to access.

MRI-guided optimisation of neoadjuvant chemotherapy duration was associated with favourable 3-year event-free survival outcomes in patients with stage II–III HER2-positive breast cancer. This approach represents a novel strategy that reduces treatment burden, minimises toxicity, and preserves quality of life in a subset of patients with early HER2-positive breast cancer.

Cancer-related NHS hospital care costs by stage at diagnosis differed between cancer types; this heterogeneous pattern could inform detailed and nuanced economic evaluations of early detection initiatives.

Adding ipilimumab and nivolumab to percutaneous hepatic perfusion significantly improved progression-free survival, but with a higher rate of adverse events. The combination therapy offers a promising new treatment paradigm for patients with metastatic uveal melanoma. These results would ideally be validated in larger, multicentre randomised trials; however, conducting such studies is challenging due to the low incidence of uveal melanoma.

This nomogram predicts ADT-free survival after MDT in oligorecurrent prostate cancer. While individual-level discrimination was modest, risk-group stratification showed meaningful separation, supporting its potential use in treatment selection.

Concurrent chemoradiotherapy followed by immune checkpoint inhibitor (ICI) consolidation is now the standard of care for unresectable stage III non-small-cell lung cancer (NSCLC) and is increasingly applied to other thoracic malignancies. Although survival outcomes have improved, concerns about cardiac toxicity have emerged, as both chemoradiotherapy and ICIs are independently cardiotoxic and their combined effects remain unclear. This scoping review first examines chemoradiotherapy-associated and ICI-associated cardiac toxicity separately, and then evaluates their convergence in combined chemoradiotherapy and ICI therapy.

Currently, no consensus exists regarding the definition of oligometastatic pancreatic ductal adenocarcinoma, its necessary diagnostic measures, and potential treatment approaches. To address these knowledge gaps, the OligoPanc project brought together an interdisciplinary group of experts to establish consensus using a modified Delphi process and clinical vignettes. Participants agreed that the number of metastatic lesions and the number of affected organs are key elements in defining oligometastatic pancreatic ductal adenocarcinoma.

Radiotherapy and systemic therapies have revolutionised cancer treatments and improved survival, with generally acceptable toxicity. Modern radiotherapy techniques offer precision in targeting tumours, while minimising harm to the surrounding tissues. Novel systemic therapies represent opportunities for combining innovative treatments with radiotherapy. New agents are increasingly more tumour-specific than chemotherapy, and new rational combinations with radiotherapy are emerging, allowing for a more personalised approach.

This international Delphi study, led by the European Society of Radiation Oncology as part of their Value-Based Radiation Oncology programme, brought together key experts from the radiation oncology community to build consensus on both the level of evidence and the endpoints that are essential to support clinical implementation or policy decisions (eg, reimbursement) for different types of radiotherapy innovations. Although randomised trial evidence remained a high priority across most innovation types, other evidence, such as high-quality prospective observational studies or alternative designs such as pragmatic trials, was found to be a suitable alternative in specific scenarios.

In March, 2026, a Working Group of 12 scientists from nine countries met at the International Agency for Research on Cancer (IARC) in Lyon, France, to finalise their evaluation of the carcinogenicity of tris(chloropropyl) phosphate (TCPP), butyraldehyde, and cumyl hydroperoxide.

The US National Cancer Institute (NCI) and the Foundation for the National Institutes of Health have launched a partnership to raise nearly US$200 million to fund clinical trials for cancer vaccines, including mRNA-based approaches for patients at high risk of tumour recurrence.

Improved risk stratification in prostate testing could ensure effective resource allocation, according to results from the OPT Stockholm3 study. In the population-based study, Ugo Falagario and colleagues (University of Foggia, Foggia, Italy) assessed whether reflex testing with Stockholm3 after PSA testing could reduce the proportion of men referred for MRI versus a PSA-only pathway. The OPT Stockholm3 pathway invited all men in the Region Stockholm Gotland in 2024 (born in 1974; Stockholm3 testing if PSA ≥2 ng/mL and if Stockholm3 ≥15 MRI) and 2023 (born in 1973; MRI if PSA ≥3 ng/mL).

Disruptions to pharmaceutical transport routes linked to the escalating conflict in the Middle East are raising alarms about the fragility of cancer medicine supply chains in low-income and middle-income countries, particularly across Africa. Routes commonly used to carry temperature-sensitive medicines—including chemotherapy drugs and other oncology supplies—have been affected as airlines and shippers avoid conflict zones, increasing costs and delaying deliveries. For patients already navigating fragile health systems, even short interruptions can have serious consequences.

The US Environmental Protection Agency (EPA) proposed changes to rollback safeguards against air emissions of ethylene oxide (EtO), a highly carcinogenic gas used to sterilise about half of all medical devices in the USA. Announced March 17, 2026, the proposed changes would, among other things, relax round-the-clock emissions monitoring requirements for about 90 commercial sterilisation facilities.

Kidney cancer is the sixth most common cancer in adults in the UK, with approximately 13 900 new cases every year.1 Kidney cancer incidence rates have almost doubled since the 1990s and are projected to rise further by 2040.2 5-year relative survival for kidney cancer in the UK is below the European average,3 and there is wide variation in provision of kidney cancer care in England and Wales.4 If found early, kidney cancer can be cured, but early diagnosis is challenging as most people (87%) in the UK with stage 1a disease are diagnosed incidentally, having no relevant symptoms.

Patient-reported outcomes (PROs) are increasingly recognised for their role in assessing tolerability in dose-finding oncology trials (DFOTs). However, analysis and reporting of PRO data within DFOTs are often unclear and inconsistent. OPTIMISE-AR (Incorporating Patient-Reported Outcomes in Dose-Finding Trials–Analysis Recommendations) establishes a practical toolkit supporting the statistical analysis, visualisation, and reporting of PRO data within DFOT publications. International, multidisciplinary, cross-sector statistical analysis and data visualisation working groups identified analytical and visualisation approaches for PROs data, addressing key DFOT PRO research objectives.

Presenting on behalf of a large international team, Martin Heidinger (DBM Hebelstrasse, Basel, Switzerland), showed results from a preplanned analysis of the TAXIS/OPBC-03 phase 3 trial. Axillary lymph node dissection (ALND) is the standard of care for patients with node-positive breast cancer after neoadjuvant chemotherapy or upfront surgery. The use of tailored axillary surgery (TAS) to reduce axillary tumour burden to a degree where radiotherapy might be able to control the remaining extent of disease could reduce morbidity.

On Feb 28, 2026, Indian Prime Minister Narendra Modi unveiled a national campaign to promote human papillomavirus (HPV) vaccination to prevent cervical cancer. During the 90-day drive, 11·5 million girls aged 14 years will be administered the vaccine for free at government-run health facilities across the country. “This is the largest free HPV vaccination campaign in history”, said WHO Director-General Tedros Adhanom Ghebreyesus (WHO, Geneva, Switzerland). After the current campaign ends, the Indian health ministry will integrate the HPV vaccine into the Universal Immunisation Programme (UIP) and make it available at government health facilities during routine immunisation days, Health Minister Jagat Prakash Nadda (New Delhi, India) announced while addressing a virtual press conference, along with Ghebreyesus, on March 5.

These findings show that AI applied to routine histopathology can serve as a practical and scalable tool for guiding chemotherapy decisions in hormone receptor-positive, HER2-negative, early breast cancer. This approach has the potential to reduce unnecessary chemotherapy and broaden access to precision oncology, particularly in resource-limited settings where genomic testing remains unavailable or unaffordable.

Benmelstobart plus anlotinib showed longer progression-free survival than pembrolizumab plus placebo and no unexpected safety signals were reported, suggesting benmelstobart plus anlotinib as a potential first-line option in driver gene-negative, PD-L1-positive, advanced NSCLC. Longer term follow-up is needed to establish effects on overall survival.

We present new risk nomograms by PROMISE along with a simple table to prognosticate 3-year, 5-year, and 7-year overall survival in prostate cancer. PROMISE and PPP3 assessments are freely available online for global implementation.

The Government of Canada and five partner organisations have committed more than CA$41 million to fund 19 cancer prevention research teams over 5 years. The announcement was made on Feb 26, 2026, at Princess Margaret Cancer Centre in Toronto by Marjorie Michel, Canada's Minister of Health. It is the single largest investment in cancer prevention research ever led by the Canadian Institutes of Health Research (CIHR).

On Feb 27, 2026, lawmakers in the UK voted to sign into law the Rare Cancers Bill. The bill was proposed by Scott Arthur, a Member of Parliament for the ruling Labour Party based in Scotland, and a medical doctor. The bill will help accelerate research innovation to improve treatments and survival for rare cancers, including brain tumours and pancreatic cancer. The new law will take effect just as the UK has launched two major plans—The National Cancer Plan for England, and The England Rare Diseases Action Plan 2026.

On Feb 26, 2026, WHO announced that South Sudan's leadership had signalled renewed political attention to cancer control after Vice President, Josephine Lagu Yanga, met with WHO officials in Juba to discuss strengthening prevention, screening, treatment, and palliative care. The talks came as the country begins to mobilise a more coordinated response to cancer.

Since 1992, the surgical treatment for melanoma has substantially changed,1 and in clinically negative nodal basin, elective lymph node dissection has been overtaken by the sentinel node biopsy (SNB) followed by complete lymph node dissection in the case of positivity to SNB at the histopathological report. Many different studies have examined these methods, looking at specific subclinical features such as micro-metastases or macro-metastases,2 SNB tumour burden,3 number of SNBs, number of positive non-sentinel lymph nodes, and number of excised non-sentinel lymph nodes.

This meta-analysis showed that people with melanoma who underwent SNB had a significantly reduced risk of death from melanoma and recurrence compared with those who did not. These findings are consistent with the only published randomised controlled trial and were robust on sensitivity analyses, indicating that SNB confers true survival and recurrence benefits.

Historically, perioperative cisplatin based neoadjuvant therapy has remained the gold standard for muscle-invasive bladder cancer. In the past 5 years, several practice changing trials have enabled the incorporation of immune checkpoint inhibitors in the perioperative setting for muscle-invasive bladder cancer. The phase 3 NIAGARA study led to the approval of durvalumab in combination with gemcitabine or cisplatin followed by adjuvant immune checkpoint inhibitor monotherapy.1 The CheckMate-274 and AMBASSADOR trials showed improved outcomes in patients treated with adjuvant immune checkpoint inhibitors.

Perioperative sacituzumab govitecan plus pembrolizumab revealed a promising clinical complete response rate, without the occurrence of grade 4 or higher adverse events, allowing a bladder preservation with sustained remission in approximately 40% of patients.

On Feb 15 (commemorating the World Childhood Cancer Day), Jordan announced three linked initiatives: a National Cancer Control Strategy 2026–2030, six national paediatric cancer clinical guidelines, and its entry into the Global Platform for Access to Childhood Cancer Medicines. The event was jointly organised by the Ministry of Health and WHO under the patronage of Princess Ghida Talal of the King Hussein Cancer Foundation and King Hussein Cancer Center (KHCC; Amman, Jordan). The event also included participation of civil society organisations supporting patients with cancer (among panellists), to foster meaningful engagement of patients in line with WHO guidance.

February 15 is International Childhood Cancer Day, with 2026 marking the cumulation of a 3-year campaign, “Equal Access to Care for All Children with Cancer.” 400 000 children are diagnosed with cancer annually and, by disability-adjusted life-years, childhood cancer ranks as the sixth leading cause of cancer burden and ninth highest in childhood disease burden. Childhood cancer is now the leading cause of non-communicable disease-related death among children and adolescents in low-income and middle-income countries (LMICS) as well as in high-income countries.

The editorial team at The Lancet Haematology would like to extend our thanks to the many experts who offered their time and expertise to help us make decisions on and improve papers in 2025. In this issue we publish a list of clinical and statistical peer reviewers—we hope that some small recognition of an important academic task can be given to those who give their time, knowledge, and expertise. The Journal's success was partially reflected in our 2024 Impact Factor of 17·7 and Scopus CiteScore of 23·8.

In their study in The Lancet Haematology, Mahé and colleagues report a post-hoc analysis of the API-CAT randomised, double-blind, non-inferiority trial, identifying predictors of clinically relevant bleeding during 12 months of extended apixaban therapy in patients with active cancer who had completed at least 6 months of anticoagulation for venous thromboembolism (VTE).1 Among 1766 participants, clinically relevant bleeding occurred in 238 patients (cumulative incidence 13·9%), including 61 major bleeding events (3·6%).

We read with interest the post-hoc analysis of the pivotal API-CAT trial by Isabelle Mahé and colleagues, published in The Lancet Haematology,1 that found anaemia and/or thrombocytopenia, age 75 years or older, pulmonary embolism as the index event, and male sex to be associated with an increased risk of clinically relevant bleeding during extended anticoagulation for cancer-associated venous thromboembolism (VTE). The authors concluded that these results were homogenous across cancer sites. However, upon closer inspection of the subgroup analyses, we noted potentially substantial heterogeneity among the identified predictors of clinically relevant bleeding according to cancer site.

We thank Faizan Khan and Nick van Es, and Zhang Cheng and Yiqi Jin for their Correspondence regarding our post-hoc analysis of the API-CAT trial1,2 in which we identified four non-cancer related, non-modifiable predictors of clinically relevant bleeding during 12 months of extended apixaban therapy in patients with cancer-associated venous thromboembolism (VTE).

Iron deficiency during pregnancy is associated with an increased risk of postpartum haemorrhage, preterm birth, pre-eclampsia, fetal growth restriction, maternal mortality, and neurodevelopmental abnormalities in infants and during early childhood.1,2 The American College of Obstetricians and Gynaecologists recommends prophylactic oral iron (30 mg per day) rather than treatment of non-anaemic iron deficiency due to insufficient high-quality evidence concerning the effect of treatment on fetomaternal outcomes.

Kabbara F, Charbel N, Klim J, et al. Thalassaemia clinical trials in war-stricken Lebanon: a story of struggle and resilience. Lancet Haematol 2026; 13: e6–7—In this In Focus piece, Ghida Ismail and Farah Ismail should have been included in the author list. Ghida Ismail's affiliation of EpiMaCT - Epidemiology of chronic diseases in tropical zone, Institute of Epidemiology and Tropical Neurology, Omega Health, University of Limoges, CHU Limoges, INSERM U1094, IRD U270, Limoges, France, should have been included and both Ghida Ismail and Farah Ismail should have been added to the affiliation of Chronic Care Center, Hazmieh, Lebanon.

My Blood, Your Blood, a new children's book by author and producer Laura Henry-Allain MBE and illustrated by Zenovia Grant, is full of heroes. Based on the real-life experience of 13-year-old Angel Salami, it follows her, aged 4 years, bravely enduring a sickle cell crisis and receiving a blood transfusion in hospital. Back playing with her friends at the end of the story, she pays tribute to the other anonymous heroes in the book: “Every day I think about the person whose blood was given to me.”

Allogeneic haematopoietic cell transplantation (HCT) remains a potentially curative option for patients with high-risk haematological malignancies, albeit at the cost of substantial morbidity and mortality. Advances in transplantation practices and supportive care have expanded eligibility to older patients and to those with significant comorbidities. In this evolving landscape, frailty assessment has become a crucial component of pre-transplantation evaluation, as it is consistently associated with increased transplantation-related complications, prolonged hospitalisation, and inferior survival.

Var-cel induced deep remissions with low incidence of severe cytokine release syndrome and any-grade immune effector cell-associated neurotoxicity syndrome, supporting fractionated dose escalation as a strategy that preserves activity, limits acute toxic effects, and supports a hospital-based approach that could expand access to CAR T-cell therapy.

Adverse events during induction and reinduction were consistent with those reported in previous infant acute lymphoblastic leukaemia studies. Infections remain a substantial cause of morbidity and mortality in this immunocompromised patient population and extended beyond the induction and reinduction chemotherapy phases.

High-dose cytarabine and mitoxantrone plus venetoclax appeared to be safe, showed promising activity, and could be a new therapeutical approach for medically fit patients with relapsed or refractory acute myeloid leukaemia, especially as a bridge to allogeneic HCT.

The results indicate that quizartinib plus standard chemotherapy prolongs overall survival without adversely affecting patient-reported outcomes and health-related quality of life, with no substantial differences between groups. Future research in real-world settings is warranted to assess the generalisability of these patient-reported outcome results.

The distinction between myelodysplastic syndromes and acute myeloid leukaemia remains a subject of debate, with direct implications for clinical decisions, trial eligibility, and allogeneic hematopoietic cell transplantation allocation. Although the historical 20% blast threshold in bone marrow is commonly used to separate myelodysplastic syndromes from acute myeloid leukaemia, emerging evidence shows that morphological, cytogenetic, and molecular features provide a more accurate framework for diagnosis and risk stratification.

A 47-year-old man was admitted to Ruijin Hospital (Shanghai, China) in July, 2025, with widespread, tender, and violaceous cutaneous nodules on his trunk and extremities. PET–CT revealed hypermetabolic activity in the skin lesions, which involved cervical and inguinal lymph nodes (maximum standardised uptake value of 3·6–7·1). Laboratory studies revealed a white blood cell count of 11 × 109 cells per L. A skin biopsy showed a diffuse dermal infiltrate of monomorphic blastoid cells. Immunohistochemical analysis revealed that the neoplastic cells expressed CD123, TCF4, TCL1, CD4, CD56, HLA-DR, and aberrant cytoplasmic CD3 (figure A), with partial expression of CD2 and CD7.

NUTM1 rearrangements define a significant subset of infant B-lineage acute lymphoblastic leukemia lacking KMT2A rearrangements. Nishimura et al integrated multiomic analyses with clinical and preclinical models, and they show a distinct molecular landscape marked by enhanced B-cell lineage commitment that differentiates NUTM1-rearranged leukemias from KMT2A-rearranged cases. The BRD9-NUTM1 fusion acts as the transforming driver while conferring chemotherapy sensitivity, providing a biological explanation for the favorable clinical outcomes observed in these patients.

In a Blood Spotlight, Ginder, Shang and Williams review recent evidence demonstrating that methylation of the γ-globin gene (HBG) promoter, acting in concert with the major silencing transcription factors BCL11A and ZBTB7A, recruits the chromatin-remodeling complex MBD2a-NuRD. This complex enforces transcriptional repression of the HBG genes by positioning a nucleosome over the promoter, thereby silencing HbF expression.

In a Review Article, Maura, Samur and Munshi examine the genomic evolution of multiple myeloma. They describe a decades-long process shaped by the interplay of inherited susceptibility, environmental exposures, and ongoing genomic selection. These events promote immune escape, ultimately enabling progression from precursor states to clinically overt disease accompanied by end-organ damage.

In the primary analysis of the phase 3 randomized trial ASC4FIRST, an allosteric inhibitor, asciminib, demonstrated superior efficacy with improved safety and tolerability compared with investigator-selected tyrosine kinase inhibitors (TKIs) in patients with newly diagnosed chronic myeloid leukemia (CML). Cortes et al now report the planned secondary (week 96) analysis with a median follow-up of 2.2 years, showing a further efficacy advantage and a consistently favorable safety profile for asciminib relative to investigator-selected TKIs, especially second-generation TKIs. The longer-term follow-up further supports asciminib as a frontline therapeutic option for patients with chronic-phase CML.

While individuals undergoing curative therapy for sickle cell disease (SCD) with gene therapy may have a predisposition to secondary myeloid malignancy, there have been conflicting reports on the prevalence of clonal hematopoiesis (CH) in SCD. Ulloa et al performed targeted sequencing for CH mutations in 2318 children with SCD and 2957 controls and found that children with SCD have a higher prevalence of CH, but there is no association with hydroxyurea therapy. Notably, the majority of CH cases identified were very small “micro-CH” clones with variant allele frequencies of <2%, and it will be important to define the clinical significance of these clones.

The deceptively named transcription factor B-cell lymphoma/leukemia 11A (BCL11A) is a central regulator of the fetal-to-adult hemoglobin switch in erythroid cells and a therapeutic target in hemoglobinopathies. Wang et al elucidate the underlying mechanism by which CRISPR-based enhancer editing silences BCL11A, and they show that it is regulated by enhancer-dependent epigenetic insulation. Disrupting epigenetic insulation silences BCL11A and reactivates fetal hemoglobin in erythroid cells, revealing a targetable vulnerability.

Enterococcus has been associated with increased graft-versus-host disease (GVHD)–related mortality in preclinical models and retrospective clinical studies, although the mechanistic basis for this association has remained uncertain. Nguyen et al demonstrate that, during GVHD, Enterococcus faecalis colonization induces major histocompatibility complex (MHC) class II upregulation on colonic epithelial cells through interferon gamma signaling derived from CD4⁺ T cells and natural killer cells. The authors posit that administration of a defined consortium of commensal bacteria to restore colonization resistance against Enterococcus and enhance propionate production is a promising strategy to mitigate GVHD.

Larger baseline tumor burden was associated with worse OS, but not PFS, and was not predictive of tumor regression after dual ICI therapy in a large cohort with rare cancer types.

CK and KIT mutations jointly identify a high‐risk subgroup within t(8;21) AML. This baseline genetic stratification provides a foundation for risk‐adapted therapy, with MRD assessment at CR offering complementary prognostic information.

H4C6/TWIST1 methylation detection is a noninvasive, highly accurate, and consistent tool with significant clinical potential for the initial diagnosis and monitoring of UCa across all grades and stages.

For most types of cancer, psychosocial factors (measured at a single point in time) were not associated with increased risk. PSS, currently not in a relationship, and loss were associated with an increased risk of lung cancer, although most effects attenuated when adjusting for several known risk factors.

On March 20, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma. The FDA also granted traditional...

As reported in The Lancet by Rivera et al, 5-year results of a French phase III trial (UNICANCER HypoG-01) showed noninferiority of hypofractionated locoregional radiotherapy (RT) vs standard 5-week RT in reducing risk of postsurgery lymphedema in patients with early breast cancer.

In a systematic review and meta-analysis reported in The Lancet Oncology, Varey et al found that patients undergoing sentinel node biopsy (SLNB) for melanoma had reduced risk of melanoma-specific mortality and disease recurrence vs those who did not undergo SLNB.

In a study (PREDICT-DNA) reported in the Journal of Clinical Oncology, Hunter et al found that an ultrasensitive assay for circulating tumor DNA (ctDNA) to detect measurable residual disease after neoadjuvant therapy in patients with breast cancer did not distinguish pathologic complete response...

The 2026 Physician Survey on Augmented Intelligence from the American Medical Association’s (AMA) Center for Digital Health and AI indicates that physician adoption of AI is increasing alongside growing confidence in the technology’s ability to address clinical challenges.

Adding hormone therapy to postprostatectomy radiotherapy may provide little survival benefit for most men with prostate cancer, especially those with very low prostate-specific antigen (PSA) levels before treatment. In the study, reported at the 2026 ASCO Genitourinary Cancers Symposium,¹ men with...

Where a person lives in the United States increasingly shapes their chances of developing and surviving cancer. A new large nationwide study by researchers at the American Cancer Society (ACS) reports a long-term shift in the high cancer burden from urban to rural areas in the United States. The...

Overall cancer incidence is similar between women who have used medically assisted reproduction and the general population, but certain cancers may occur at slightly higher rates, according to an Australian population–based cohort study published in JAMA Network Open by Vajdic et al. 

As the incidence of cancer among reproductive-age people continues to increase in the United States—with approximately one out of every 1,000 pregnancies complicated by cancer—the Society for Maternal-Fetal Medicine (SMFM) has issued its first evidence-based clinical guidance for diagnosing and...

A new analysis suggests that prostate cancer screening may compare favorably with screening for breast cancer in terms of identifying significant cancers, reducing mortality, and avoiding unnecessary harms, according to findings presented at the 2026 Annual Congress of the European Association of...

One in 10 patients who present to the emergency department with visible hematuria may die within 3 months, new research from the United Kingdom has indicated. The WASHOUT study, presented at the European Association of Urology Congress (EAU26) in London, found that a scan administered within 48...

A PSMA-11 PET/CT scan with gallium Ga-68 led to the identification of more aggressive prostate cancer cells in men with equivocal or nonsuspicious findings on multiparametric MRI than a standard biopsy, according to first results from the phase III PRIMARY2 trial presented at the 2026 Annual...

The members of the American Association for Cancer Research (AACR) have elected Robert H. Vonderheide, MD, DPhil, as the AACR President-elect for 2026–2027. Dr. Vonderheide will become President-Elect on Monday, April 20, during AACR’s Annual Business Meeting of Members at the AACR Annual Meeting...

A novel KRAS G12D inhibitor produced disease control in almost 80% of patients with heavily pretreated advanced or metastatic KRAS G12D–mutated pancreatic cancer in an early-phase study reported at the 2026 ASCO Gastrointestinal Cancers Symposium.

The combination of the NECTIN4-directed antibody drug conjugate enfortumab vedotin-ejfv and the immunotherapy drug pembrolizumab is the established first-line standard-of-care treatment for patients with locally advanced/metastatic urothelial carcinoma.

As reported in JAMA Oncology by Yang et al, the 3-year follow-up of the predominantly Chinese phase III RATIONALE-309 trial showed a maintained progression-free survival benefit with the addition of first-line tislelizumab to chemotherapy in patients with recurrent or metastatic nasopharyngeal...

Romiplostim was beneficial in treating chemotherapy-induced thrombocytopenia, according to findings from the global phase III RECITE trial published in The New England Journal of Medicine. 

Women are more likely to survive cancer than men, but face a higher risk of serious and adverse side effects from treatment, according to a landmark international study. Published by Chhetri et al in the Journal of the National Cancer Institute, the research identified consistent differences...

In a Chinese phase III trial (CAMPASS) reported in The Lancet Oncology, Zhong et al found that the PD-L1 inhibitor benmelstobart plus the tyrosine kinase inhibitor anlotinib significantly improved progression-free survival vs placebo plus pembrolizumab in the first-line treatment of PD-L1–positive...

New research assessing the efficacy of optical genome mapping (OGM) in a group of patients with acute leukemia has demonstrated that the method provided reliable and robust analytical performance with high sensitivity and specificity in detecting genetic alterations. In nearly 20% of cases,...

In a study reported in The Lancet Oncology, Karpinski et al developed a new prostate cancer risk classification using PSMA-PET Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE; PPP) nomograms (PPP3) to provide prognostic values for overall survival at 3, 5, and 7 years.

The U.S. Food and Drug Administration (FDA) has launched a new platform, called the FDA Adverse Event Monitoring System (AEMS), for analyzing adverse events from drugs and products. The platform consolidates multiple prior reporting systems in an effort to modernize and increase transparency into...

Recurrence-free survival was similar between adjuvant therapy with the PD-1 inhibitor pembrolizumab and placebo in patients with hepatocellular carcinoma who achieved a complete radiologic response after surgical resection or local ablation, based on the phase III KEYNOTE-937 trial.¹

A population-level cohort study of 264.4 million deaths across 20 countries found that females born since the 1930s had higher cancer mortality than males between the ages of 35 and 60 years, largely due to breast and gynecologic cancers. Although females live longer than males on average, these...

Right ventricle (RV) dysfunction is associated with poorer outcomes in heart failure with preserved ejection fraction (HFpEF). Females are more likely to have HFpEF but males have worse prognosis and resting RV function. The contribution of dynamic RV-pulmonary artery (RV-PA) coupling between sex and its impact on peak exercise capacity (VO2) in HFpEF is not known.

A Phase I, single-center investigation demonstrated that 8 weeks of antimycobacterial therapy improved sarcoidosis forced vital capacity (FVC). Safety and efficacy assessments have not been performed in a multicenter cohort.

All aspects of medical education were affected by the Novel Coronavirus Infectious Disease-19 (COVID-19) pandemic. Several challenges were experienced by trainees and programs alike due to the economic repercussions of the pandemic, how social distancing affected the delivery of medical education, testing and interviewing, how the surge of patients affected redeployment of personnel, potential compromise in core training and the overall impact on the wellness and mental health of trainees and educators.

In this meta-analysis of observational studies, RV dysfunction was associated with higher short-term and long-term mortality in sepsis and septic shock.

Legionella is an uncommon cause of CAP, occurring primarily from late spring through early autumn. Testing is uncommon, even among patients with risk factors, and many positive patients failed to receive empiric coverage for LP.

The nS classification could be used to provide a more accurate prognosis in patients with resected NSCLC. The nS is worth taking into consideration when defining nodal category in the forthcoming ninth edition of the staging system.

NLP successfully identified a large cohort with CC. Most patients were identified through NLP alone, rather than diagnoses or medications. NLP improved detection of patients nearly seven-fold, addressing the gap in ability to identify and characterize CC disease burden. Nearly all cases appeared to be managed in primary care. Identifying these patients is important for characterizing treatment and unmet needs.

Pulmonary arterial hypertension (PAH) is a rare disease and much of our understanding stems from single-center studies, which are limited by sample size and generalizability. Administrative data offer an appealing opportunity to inform clinical, research, and quality improvement efforts for PAH. Yet, there is currently no standardized, validated method to distinguish PAH from other subgroups of pulmonary hypertension (PH) within this data source.

A transparent DL algorithm improves on traditional clinical criteria to predict the need for MV in hospitalized patients, including in those with COVID-19. Such an algorithm may help clinicians optimize timing of tracheal intubation, better allocate resources and staff, and improve patient care.

To assess airway and lung parenchymal damage non-invasively in cystic fibrosis (CF), chest MRI has been historically out of the scope of routine clinical imaging due to technical difficulties such as the low proton density and respiratory and cardiac motion. However, technological breakthroughs have recently emerged to dramatically improve lung MRI quality (including signal-to-noise ratio, resolution, speed, contrast). At the same time, novel treatments have changed the landscape of CF clinical care.

Bronchoscopic lung volume reduction with one-way endobronchial valves is a guideline treatment option for patients with advanced emphysema, supported by extensive scientific data. Patients limited by severe hyperinflation, with a suitable emphysema treatment target lobe and with absence of collateral ventilation are the responders to this treatment. Detailed patient selection, a professional treatment performance, and dedicated follow-up of the valve treatment, including management of complications, are key ingredients to success.

Chronic Obstructive Pulmonary Disease (COPD) may cause profound dyspnea, functional impairment, and reduced quality of life. Available pharmacologic therapy provides suboptimal symptom improvement in many patients. Bronchoscopic lung volume reduction (BLVR), achieved with endobronchial valve (EBV) placement, can effectively improve dyspnea and functional status in appropriately selected patients. Operationalizing a safe and effective BLVR program requires appropriate oversight which can be achieved by a BLVR Nurse Coordinator (NC).

Empathy-based, stigma-reducing communication may lead to improved assessments of tobacco use and smoking cessation for patients with smoking-related cancers. These findings support the dissemination and further testing of a new ECS model for training OCPs in best practices for assessment of smoking history and engagement of patients who currently smoke in tobacco treatment delivery.

In clinical practice, reslizumab may have been initiated in response to heavy symptom burden and CAEs. Reslizumab was associated with improved clinical and patient-reported outcomes and significant reductions in asthma-related HRU.

Quantitative emphysema measured on LDCT of the chest can be leveraged to improve lung cancer risk prediction and help diagnose COPD in individuals who currently or formerly smoked undergoing lung cancer screening.

Cancer screening is an effective strategy for reducing cancer mortality, but in resource-constrained settings the key challenge is not simply whether screening works but how its implementation should be prioritized. We propose a framework for prioritizing cancer screening under resource constraints, summarized in three ‘not all’ principles: not all cancers are suitable for screening; not all individuals need screening; and not all high-performance technologies are appropriate for population screening.

This Comment describes the clinical significance of the Mammography Screening with Artificial Intelligence (MASAI) trial, which is, to the best of our knowledge, the first randomized trial of artificial intelligence-supported mammography interpretation to examine interval cancer as an outcome. This trial used artificial intelligence to assign single-reading versus double-reading of mammograms and found that this approach does not increase interval cancers in the Swedish population.

Neoadjuvant GOLP is effective in high-risk intrahepatic cholangiocarcinoma

Author Correction: Innovative approaches for lung cancer screening and interception

The development of immune checkpoint inhibitors and novel targeted therapies and the incorporation of these agents into first-line therapy for biomarker-selected patients with metastatic gastric cancer has improved outcomes. Nonetheless, many challenges remain, including both primary and acquired resistance as well as a lack of relevant biomarkers in certain subgroups. In this Review, the authors describe the current approach to first-line therapy for patients with metastatic gastric cancer as well as emerging approaches that might improve the standard of care in the coming years.

Glucagon-like peptide 1 receptor agonists (GLP1RAs) are widely used by individuals with type 2 diabetes mellitus (T2DM) and/or obesity. Both of these conditions are also associated with an increased risk of certain cancers, and this risk might be ameliorated following intentional weight loss, which can consistently be achieved with GLP1RAs. Conversely, several reports have suggested an increased risk of certain cancers, such as medullary or non-medullary thyroid cancer and pancreatic cancer among those receiving GLP1RAs. In this Review, the authors evaluate these competing risks and the underlying evidence as well as highlighting areas in which evidence is limited and more research will be needed in order to definitively understand the implications of GLP1RAs for cancer risk.

Although oncology advances stem from clinical research, <5% of global cancer trials actively recruit patients in Latin America. Herein, I discuss why expanding inclusive trial designs and fostering multisector partnerships are essential to reduce disparities and improve the role of Latin America in global oncology research. I present examples such as the recent regulatory reforms in Brazil that aim to accelerate study approvals, as well as collaborative initiatives between local and international research groups to further strengthen clinical trial capacity.

Lisocabtagene maraleucel has high efficacy in R/R MZL

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Beam is now in the strongest position of all companies advancing a genetic therapy for alpha-1 antitrypsin deficiency, according to analysts at William Blair.

Besting Vertex Pharmaceuticals’ kidney disease asset wasn’t enough to impress Wall Street, which appears to be “getting hung up” with the broad population data in Maze Therapeutics’ trial, according to Mizuho.

Aardvark Therapeutics’ obesity asset is based on its lead molecule, which in February was linked to reversible heart safety signals in a healthy volunteer study.

Pfizer has a lofty goal for the CDK4 inhibitor atirmociclib, the New York pharma’s answer to Ibrance’s loss of patent protection next year. In 2025, Ibrance led Pfizer’s oncology portfolio with $1.04 billion in sales.

With Ascendis Pharma entering the achondroplasia space last month and BridgeBio on deck, BioMarin faces competition. Adding to the pressure, the company suffered a setback Monday when it halted two studies of Voxzogo in other growth-related conditions following multiple cases of hip injuries in other trials of the drug.

Structure Therapeutics’ oral obesity drug elicited a placebo-adjusted weight loss of 16.3% at 44 weeks in a Phase 2 trial. The biotech is planning to launch a late-stage program for the drug later this year.

In this episode of Denatured, you’ll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA’s latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.

Dyne Therapeutics is plotting an approval application for z-rostudirsen in the back half of 2026—a push that will only be bolstered by the departure of controversial CBER chief Vinay Prasad, according to analysts at Stifel.

Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package.

Zealand Pharma’s shares fell 32% in early morning trading Friday after its Roche-partnered asset petrelintide failed to meet investor expectations in a mid-stage clinical trial.

Missing one of its co-primary endpoints could make it difficult for Karyopharm Therapeutics to score conventional approval for Xpovio in myelofibrosis, according to Jefferies analysts.

The multivalent candidate, being developed by Pfizer and French partner Valneva under a 2020 pact, generated higher than 73% efficacy against the tick-borne disease in a Phase 3 trial—but failed to hit a predetermined confidence interval.

Eli Lilly’s retatrutide could present a “differentiated option” for patients with type 2 diabetes who want to control their blood sugar and achieve maximal weight loss, according to analysts at BMO Capital Markets.

Gossamer Bio reported last month that its only late-stage candidate failed a Phase 3 study in pulmonary arterial hypertension, casting doubt on the asset’s future prospects.

The Phase 3 EMANATE study is a basket trial looking at the efficacy of Rhythm Pharmaceuticals’ injectable obesity drug across four types of obesities driven by specific genetic mutations.

In this episode of Denatured, you’ll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA’s latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.

Vertex Pharmaceuticals has a rolling biologics license application with the FDA for povetacicept in IgA nephropathy. With new data from RAINIER, the biotech expects to complete its submission by the end of March.

Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package.

Roche’s shares tumbled nearly 5% on news that a key pillar in the five-pronged clinical plan for the breast cancer asset giredestrant was unsuccessful.

Azetukalner, a Kv7 potassium channel opener, reduced the frequency of focal onset seizures by a placebo-adjusted rate of 42.7%. Xenon Pharmaceuticals believes this is the highest such efficacy “observed in a pivotal epilepsy study,” CEO Ian Mortimer said Monday.

While participants on a lower dose of Wave Life Sciences’ RNA therapy lost 5.3% total fat at the six-month mark, those receiving the higher dose saw a less than 1% drop at three months.

Beam is now in the strongest position of all companies advancing a genetic therapy for alpha-1 antitrypsin deficiency, according to analysts at William Blair.

In this episode of Denatured, you’ll listen to Sergey Jakimov, managing partner at LongeVC and Artem Trotsyuk, operating partner, US, LongeVC. We speak about how developers in the longevity space should stop chasing aging as an abstract target and concentrate on specific mechanisms that can clearly tackle age-related conditions.

Besting Vertex Pharmaceuticals’ kidney disease asset wasn’t enough to impress Wall Street, which appears to be “getting hung up” with the broad population data in Maze Therapeutics’ trial, according to Mizuho.

Missing one of its co-primary endpoints could make it difficult for Karyopharm Therapeutics to score conventional approval for Xpovio in myelofibrosis, according to Jefferies analysts.

Overall, the top 16 largest pharmaceutical companies spent $159 billion on research and development in 2025, compared to $165 billion the year prior. Here’s where all that cash went at companies like Johnson & Johnson, Amgen and Pfizer.

Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.

Aardvark Therapeutics’ obesity asset is based on its lead molecule, which in February was linked to reversible heart safety signals in a healthy volunteer study.

The multivalent candidate, being developed by Pfizer and French partner Valneva under a 2020 pact, generated higher than 73% efficacy against the tick-borne disease in a Phase 3 trial—but failed to hit a predetermined confidence interval.

Longevity is a long-standing buzzword in life sciences, but it now has staying power. The smart trajectory is to stop chasing aging as an abstract target and concentrate on specific mechanisms that can clearly target specific, age-related diseases, according to two investors in a discussion with BioSpace.

On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.

On March 20, 2026, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).

On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. 

On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024. 

On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech, Inc.). See the prescribing information for the specific indications.

On December 17, 2025, the Food and Drug Administration approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx).

On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.

On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.

On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy

On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

On November 25, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.

On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.

On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.

On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.

On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024). 

On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta.

On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.

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