Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...

Sarepta (SRPT) plans to continue Elevidys shipments for Duchenne muscular dystrophy, despite FDA request not to do so after ...

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 ...

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

Sarepta Therapeutics (NasdaqGS:SRPT) recently provided updates that may have influenced its stock performance. The announcement of a safety update for ELEVIDYS, concerning severe side effects and ...

FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety and regulatory concerns.

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, the agency is investigating two Duchenne muscular dystrophy patient ...

On June 15, 2025, the Company disclosed that a second patient had died of acute liver failure following treatment with ELEVIDYS, leading to Sarepta suspending shipment of ELEVIDYS for non ...