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 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 ...

The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne muscular dystrophy who were treated with Sarepta Therapeutics’ gene therapy ...

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 ...

Elaine Chen covers biotech, co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70. Adam Feuerstein is ...

Pharmalittle: We’re reading about a Sarepta setback with a DMD drug, FDA workload causes a delay, and more Nonprofit led by 23andMe co-founder Anne Wojcicki won a last-minute bidding war to buy ...

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 ...