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

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

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

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

The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.

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

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

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

On a conference call, CEO Doug Ingram said the decision to cut 36% of the company's staff and halt several drug programs was ...

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...