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FDA to Ask Sarepta to Halt Elevidys Shipments

· 2h · on MSN

Exclusive-US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

By Bhanvi Satija (Reuters) -The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy Elevidys, a source familiar with the matter told Reuters on Friday.

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· 3h · on MSN

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths

Sarepta to cut 500 jobs after gene therapy setback, shares jump

Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

The U.S. Food and Drug Administration will request Sarepta Therapeutics (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Fri...

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Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting

Sarepta Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript

3h

F.D.A. to Ask Biotech Company to Stop Shipping Treatment Linked to Patient Deaths

Three patients with a muscle-wasting disease died from liver failure after taking the therapy, Elevidys, or a similar treatment.

9h

Patient dies in Sarepta gene therapy trial, adding to safety concerns

The death will likely further stoke safety concerns around Sarepta's gene therapies, as well as raise questions around the company’s transparency.

1mon

Roche Pauses Commercial and Clinical Use of Elevidys After Fatal Liver Failures

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

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Food and Drug Administration