Notably, he condemned the approval of Sarepta’s Duchenne muscular dystrophy drug, Elevidys, asserting that there was insufficient evidence to demonstrate it effectively slowed or reversed symptoms of ...

Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...

Vinay Prasad has stepped down as head of the FDA’s biologics division just two months into the job, following growing ...

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...

The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...

Shares of Sarepta Therapeutics Inc. (SRPT) traded 20% higher on Tuesday afternoon after the U.S. Food and Drug Administration ...

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...

Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.