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FDA to Ask Sarepta to Halt Elevidys Shipments

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FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, according to a person familiar with the matter.

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Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy
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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FDA to ask Sarepta to stop shipping Duchenne gene therapy
Sarepta Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
FDA Commissioner Marty Makary told Bloomberg News in an interview that he was "taking a hard look" at whether a gene therapy from Sarepta should remain on the market.

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Sarepta's Setback Deepens With Another Gene Therapy Fatality
Becker's Hospital Review · 14h
Sarepta reports 3rd patient death after gene therapy treatment
Drugmaker Refuses F.D.A. Request to Pull 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.
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.
Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting
The drastic cost-cutting move follows the deaths of two teenagers that forced the company to restrict usage of its gene therapy for Duchenne muscular dystrophy.
Sarepta to cut 500 jobs, add black-box warning on gene therapy
Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two patients who were on the medicine.
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