The death poses one if the first big tests for Vinay Prasad, the new head of the FDA’s gene therapy division, who as an ...

Sarepta Therapeutics ( NASDAQ: SRPT) fell ~38% in the premarket on Monday after the company reported a second fatality from ...

Sarepta Therapeutics Inc. plummeted in early trading after reporting a second patient died of acute liver failure while being treated with its gene therapy for a rare muscle disorder.

Sarepta Therapeutics said it has temporarily suspended shipments of Elevidys® (delandistrogene moxeparvovec-rokl) for ...

The US FDA says it plans to use artificial intelligence to help speed the approval of new drugs and medical devices.

Yesterday, the New York Times reported that the FDA, in collaboration with USDA and other government agencies, plans to ...