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News

FDA to Ask Sarepta to Halt Elevidys Shipments

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 · 1h · on MSN
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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 · 3h · on MSN
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
MSN · 2d
Sarepta to cut 500 jobs after gene therapy setback, shares jump
2h
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 ...
10h
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 ...
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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