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

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

After turning down several new drugs and restricting use of another, Dr. Vinay Prasad drew the ire of the right-wing ...

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

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

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 ...

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

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 ...

Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.

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.

Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...