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FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients
Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days after the agency requested that the company halt all shipments of the one-time treatment following reports of three deaths among patients who had received a Sarepta gene therapy, including two on Elevidys.
Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...
Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug ...
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...
Sarepta shares gained even though the U.S. Food and Drug Administration said late Friday that it was probing the death of an ...
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Parents urge FDA to restore gene therapy after distribution pauseA recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
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