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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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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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Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy
A 51-year-old man died last month after receiving an experimental gene therapy developed by Sarepta Therapeutics for an ultra-rare form of muscular dystrophy, a company spokesperson confirmed Thursda...

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Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
FDA to ask Sarepta to stop shipping Duchenne gene therapy
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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STAT · 1d
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says
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