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FDA to Ask Sarepta to Halt Elevidys Shipments

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Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics (SRPT.O) on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental trea...

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Sarepta Refused FDA’s Request to Halt Elevidys Shipments
Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient r...

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FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
Sarepta Says It Won't Comply With FDA Request to Stop Shipping Gene Therapy Elevidys
Wall Street analysts have said the third death could amplify patient hesitancy to use Elevidys, given both the therapies use the same delivery vehicle known as adeno-associated virus vector.

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FDA to ask Sarepta to stop shipping Duchenne gene therapy
STAT · 17h
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from liver failure after taking it 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 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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