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

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

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 ...

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

By Bhanvi Satija and Siddhi Mahatole (Reuters) -Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as ...

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

The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, ...

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

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.

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...