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

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

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

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died ...

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Sarepta Therapeutics shares closed over 5.3% lower on Monday, hitting more than a nine-year low, and fell another 8.5% in ...

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

Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...

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

Sarepta Therapeutics Announces That FDA has Lifted its Clinical Hold on SRP-5051 for the Treatment of Duchenne Muscular Dystrophy Sep. 06, 2022 8:30 AM ET Sarepta Therapeutics, Inc. (SRPT) ...

Shares of Sarepta Therapeutics SRPT plunged almost 20% on Mar 16, soon after the company announced the FDA's decision to hold an unexpected advisory meeting for the biologics license application ...