The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease, breaking the ...
Former FDA Commissioner Dr. Scott Gottlieb joins "Squawk Box' to discuss the FDA's new framework for accelerating the development of individualized therapies for rare genetic diseases, how the new ...
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 ...
12dOpinion
One Exit Won’t Cure the FDA’s Culture
The agency’s mindset remains: evidentiary maximalism detached from clinical reality, indifference to patient urgency, and ...
A panel of conservative judges has revived a lawsuit over the Food and Drug Administration’s statements about the anti-parasitic and de-worming drug ivermectin—statements meant to clarify that the ...
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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