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

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

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

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

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

After our editorial, the agency relents to allow a Duchenne treatment.

In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...

Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.

Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug ...

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 ...

Vinay Prasad has stepped down as head of the FDA's Center for Biologics Evaluation and Research (CBER), less than three ...

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