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 ...

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

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

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, ...

Sarepta's stock drops on ELEVIDYS safety concerns, yet potential remains for ambulatory patients. Click here to read an analysis of SRPT stock now.

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

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

Sarepta’s shares crashed 41% in premarket trading Monday morning to $21.01 after the biotech reported a second death from ...

Duchenne muscular dystrophy families are sharing stories about Elevidys complications on social media. But they aren’t ...