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Sarepta Therapeutics saw its stock drop by 26% on 6 May after the US Food and Drug Administration (FDA) announced that Vinay Prasad will lead its Center for Biologics Evaluation and Research (CBER ...
Sarepta said in an email to Reuters, "The FDA communication was triggered by our report to the FDA and our suggested update to the label to include information relating to the recent events." ...
Sarepta Therapeutics, Inc. SRPT stock experienced a steep decline of approximately 40% in premarket trading on Monday following a sobering safety update for its Duchenne muscular dystrophy (DMD ...
(RTTNews) - Sarepta Therapeutics (SRPT), Wednesday announced that the FDA has designated its rAAVrh74 viral vector used in the investigational gene therapy SRP-9003 for limb-girdle muscular ...
FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...
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 ...