The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease, breaking the ...
The FDA’s recent announcement to reduce, and in some cases replace, animal testing for monoclonal antibodies and other ...
Dr. Vinay Prasad is out at the Food and Drug Administration for the second and hopefully last time within the past 12 months.
FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...
After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance ...
FDA replaces seven fragmented adverse event databases with AEMS, enabling real-time safety signal access for pharmaceutical manufacturers and researchers. On March 11, the FDA launched a unified ...
The FDA’s Breakthrough Devices Program is designed to accelerate development and review of devices that offer meaningful advances in care for serious or life-threatening conditions. With more than ...
Green Matters on MSN
Cream cheese recall receives FDA's highest rating
The FDA has shared a recall of Made Fresh Salads cream cheese as of Feb. 20, 2026, due to concerns about possible listeria ...
WASHINGTON (AP) — The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according ...
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