Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...

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, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...

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.

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 ...

Sarepta stock jumped after the drugmaker resumed shipments of the medicine Elevidys, previously paused by request by the FDA, ...

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 ...