FDA actions, approvals, policy shifts, and compliance—how rules change timelines and probability.
Clinical readouts, a large pharma deal and recent policy moves have pushed psychedelics closer to a real commercial test in psychiatry. The remaining question is less whether the drugs can work than whether sponsors can scale them into routine care.
Clinical readouts, a large pharma deal and recent policy moves have pushed psychedelics closer to a real commercial test in psychiatry. The remaining question is less whether the drugs can work than whether sponsors can scale them into routine care.
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Sanofi told patient groups and physicians in the U.S. and Europe that supplies of Myozyme and Nexviazyme are dwindling. The shortages emerged shortly after the Food and Drug Administration warned the company over manufacturing issues at its Irish facility.
The Trump administration said it is starting the process to decertify Kentucky-based organ procurement organization Network for Hope over what it called persistent safety failures. The move puts operational safeguards in organ donation under sharper federal scrutiny at a time when more than 100,000 people remain on the transplant list.
The NIH’s move to block international students on visas from the K99 Pathways to Independence program ignites discussion over the future of biomedical research careers and U.S. science leadership.
The Department of Justice has reached a third settlement with a healthcare clinic involving the provision of transgender care, amid mounting legal and political pressures across the U.S. healthcare landscape.
A reported government policy shift has delayed price negotiations on a costly blockbuster AbbVie drug by seven years, raising questions about Medicare policy and its broader impact.
The Medicare ACCESS pilot highlights a new approach to chronic care management, but withholds vital details on provider participation from patients. Simultaneously, health regulators are engaging industry stakeholders on the evolving landscape of AI regulation.
The FDA approved mFLUSIVA, Moderna’s mRNA influenza vaccine, for adults 50 and over. It beat standard-dose shots by 26.6% in Phase III, and reaches the market behind better Pfizer data.
The recent announcement of a child's death during a gene-editing trial in China has sparked renewed scrutiny over the transparency and safety of clinical research, raising ethical and regulatory questions about investigator-led studies worldwide.
The Ebola outbreak in eastern Congo has become the fastest-growing in history, with more than 1,700 fatalities as local communities and international health leaders grapple with mounting challenges.
A new analysis challenges the justification for exempting orphan drugs from Medicare pricing negotiations, fueling an ongoing debate about access, cost control, and pharmaceutical innovation.
