The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...

Sarepta Therapeutics (SRPT) said late Monday it will pause all shipments of its Duchenne muscular dystrophy gene therapy, ...

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the ...

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...

Sarepta Therapeutics said on Monday that it will pause all shipments of its Elevidys gene therapy in the United States after a muscular dystrophy patient who received a different, experimental ...

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

Sarepta Therapeutics faces challenges as the FDA halts gene therapy trials for LGMD and revokes AAVrh74 platform designation.

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...

Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...

Children's Hospital Los Angeles, citing recent U.S. Food and Drug Administration actions, on Monday said it has paused usage of Sarepta Therapeutics' gene therapy Elevidys in all patients with ...

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.