Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Sarepta Therapeutics, Inc. (NASDAQ: ...

Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...

A spokesperson for the Department of Health and Human Services confirmed that Dr. Vinay Prasad, who led the FDA’s Center for ...

Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy raised questions about a key FDA official who broke with Trump on regulation.

While MSN reports that Sarepta’s stock price began to rise on Monday on the heels of the announcement, 5 the company is still ...

Sarepta will soon resume shipping Elevidys for ambulatory Duchenne muscular dystrophy patients after a review of safety data ...

The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...

Sarepta Therapeutics said it will resume shipments of its gene therapy Elevidys® (delandistrogene moxeparvovec-rokl) “imminently” to ambulant patients with Duchenne muscular dystrophy (DMD), ending a ...

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