Dr. Vinay Prasad, the controversial critic of the US Food and Drug Administration who took a top role at the regulatory agency in May, has resigned less than three months into the job.

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 ...

Vinay Prasad, the U.S. Food and Drug Administration's chief medical and science officer, has left the health regulator, the U ...

Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his handling of Sarepta Therapeutics Inc.’s gene therapy. “Dr. Prasad did not want to ...

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

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 ...

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.

Apellis Pharmaceuticals won approval from the FDA to expand the use of its drug Empaveli to include treatment for patients ...