The agency said it will evaluate whether regulatory action is needed after investigating the deaths of two patients treated ...

Editas Medicine (NASDAQ: EDIT) and Sarepta Therapeutics (NASDAQ: SRPT), two biotech companies, have encountered severe ...

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

The FDA is assessing the need for “further regulatory action” on Sarepta's Duchenne muscular dystrophy gene therapy in the ...

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...

Elevidys has been given full approval to treat ambulatory patients with DMD, with an accelerated approval in non-ambulatory ...

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 a ...

The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver ...

Sarepta has issued a safety update regarding Elevidys (delandistrogene moxeparvovec-rokl) following a second reported case of acute liver failure resulting in death.

The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is one of the Massive Sell-Offs: These 10 Stocks Shockingly Nosedived. Sarepta ...

Sarepta shares face pressure after a second Elevidys-linked death and analyst downgrade over safety concerns and lowered revenue prospects.