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

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

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

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

As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we ...

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

Kostas Biliouris, BMO Capital Markets biotech analyst, joins CNBC's 'Squawk on the Street' to discuss the latest details on ...

The FDA requested Sarepta voluntarily stop distributing Elevidys after the death of a third patient who received one of the firm's gene therapies.

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

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...

Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug ...

Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) plunged 10% after the company disclosed that the U.S. Food and Drug ...