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The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...
Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.
Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task ...
The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the therapy, Elevidys.
Vinay Prasad has stepped down as head of the FDA’s biologics division just two months into the job, following growing ...
The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...
Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting By Jason Mast and Adam Feuerstein STAT,Updated July 16, 2025, 5:09 p.m. 13 ...
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...