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FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
Sarepta finally gets some good news: A patient death wasn’t its DMD drug’s fault.
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
Fierce Pharma4d
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 ...
FDA’s Prasad Exits Following Political Backlash Over Sarepta
Vinay Prasad, a top regulator at the US Food and Drug Administration, ended his short tenure at the agency after conservative ...
Sarepta Stock Rises Despite Downgrade and FDA Probe. The Crisis Explained.
Sarepta shares gained even though the U.S. Food and Drug Administration said late Friday that it was probing the death of an ...
Fierce Pharma16h
Untangling Sarepta’s gene therapy fallout and a growing trust deficit
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
News Nation on MSN4d
Parents urge FDA to restore gene therapy after distribution pause
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.