Regulation on Bench to Bed: FDA approval pathways, Accelerated approval and confirmatory trials, Advisory committees, Breakthrough and fast track designations, EMA and international divergence and Post-market surveillance.
The FDA has expanded approval of nogapendekin alfa inbakicept-pmln (Anktiva) with BCG to treat adults with BCG-unresponsive, high-grade papillary-only non-muscle invasive bladder cancer.
Helen Branswell, a pioneering medical journalist and co-founder of STAT, has died at age 69. Her death on Tuesday in an Ottawa hospital followed complications from cancer, according to her sister.
The FDA has approved pirtobrutinib (Jaypirca) for first-line treatment of adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Regeneron and Sanofi have expanded their long-standing collaboration with an $8 billion deal to co-develop four next-generation immunology drugs.
The FDA has opened a continuous nomination process for scientific experts and consumer representatives to join its advisory committees.
FDA reviewers identified no major safety or accuracy concerns with Grail's Galleri multi-cancer early detection blood test.
The FDA has postponed its approval decision for Exelixis' oral kinase inhibitor zanzalintinib in metastatic colorectal cancer, requesting updated data.
The FDA granted accelerated approval to AstraZeneca's camizestrant (Etcamah) for HR-positive, HER2-negative breast cancer patients with an ESR1 mutation.
A small trial found adjunctive ketamine was more effective than midazolam for treatment-resistant bipolar depression.
The first FDA-approved PROTAC drug for breast cancer has validated a new class of medicines that work by bringing proteins together.
A secret shopper study in JAMA Health Forum reveals compounded GLP-1 drugs for weight loss remain widely available in West Virginia and Oklahoma.
The FDA has approved Ionis Pharmaceuticals' Zanvastro, the first treatment for the rare neurological disorder Alexander disease.
The FDA has granted accelerated approval to AstraZeneca's Etcamah for HR-positive, HER2-negative advanced breast cancer with ESR1 mutations.
UniQure has submitted AMT-130, a gene therapy for Huntington's disease, to the FDA for accelerated approval based on three-year data showing it can slow disease progression.
The ASPIRED trial found that immediate 14-day cardiac monitoring for emergency department patients with unexplained fainting doubled arrhythmia diagnosis.
JAMA has appointed new editors-in-chief for its specialty journals and named its full editorial board and staff for the coming year.
Takeda's orexin-mimicking drug Orzeyful won FDA approval in August for narcolepsy type 1, with experts dubbing the class the 'GLPs of neuroscience' for its broad potential.
A Lancet editorial published on August 29, 2026, argues that political focus on COVID-19 origins is hindering preparedness for emerging biosecurity threats.
Revolution Medicines' pancreatic cancer therapy Rasonque cleared FDA approval via priority review voucher, marking a major advance for second-line treatment.
The FDA has granted approval to the RAS inhibitor daraxonrasib for adults with metastatic pancreatic ductal adenocarcinoma who have progressed on prior therapy or cannot receive multi-agent regimens.
The FDA has issued a discussion paper on regulating generative AI-enabled medical devices.