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

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

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS ...

Sarepta is facing a shareholder lawsuit over ELEVIDYS-related deaths. Robbins LLP cites safety risks and stock losses.

The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.

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

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

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

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

Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hund ...

Elevidys is a one-time treatment administered through a single intravenous dose. Initial approval was for children aged 4-5 years with DMD and a confirmed mutation in the DMD gene.