Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, the Food and Drug Administration said Friday.

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...

A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...

Three patients with a muscle-wasting disease died from liver failure after taking the therapy, Ele­vidys, or a similar ...

The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a ...

Sarepta Therapeutics saw its shares plunge more than 35% Friday after a third patient death tied to its gene therapy programs ...

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk.

US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from ...

The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...

The Trump administration’s proposed cuts to medical research and health agencies will curtail the development of promising ...

Health Secretary Robert F. Kennedy Jr. and other Trump officials are signaling their interest in approving psychedelic drugs ...

The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The ...