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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.
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...
FDA recommends lifting the hold on Sarepta's gene therapy Elevidys for ambulatory patients after investigation; ...
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