FDA approves Eli Lilly weight-loss pill Foundayo
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April 1 (Reuters) - The U.S. Food and Drug Administration on Wednesday clarified its policies on compounded versions of popular GLP-1 drugs, signaling tighter limits on their production as national supply conditions improve.
Denali Therapeutics (DNLI) added ~9% in the premarket on Wednesday after the U.S. Food and Drug Administration (FDA) approved its lead candidate, tividenofusp alfa, as a treatment for Hunter syndrome,
Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency is recalibrating its evidentiary standards to align wit
This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter. When Sarepta Therapeutics revealed this month that a confirmatory trial for two of its marketed Duchenne muscular ...
While it would be presumptuous to base conclusions solely on the number of drugs the FDA approved in 2025, it is noteworthy that FDA nods of new treatments fell short of previous years, though a surge of green lights in December helped make the final ...