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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 re...

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Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
Devdiscourse · 2h
Sarepta Defies FDA Order Amidst Gene Therapy Controversies
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 · 16h
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Gene-therapy company to eliminate 21 Durham employees as part of major restructuring
Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an effort to cut annual operating costs by hundreds of millions of dollars.
Researchers used gene therapy to restore hearing in adults
Groundbreaking new research shows that it is possible to use gene therapy to restore hearing in both children and adults.
Fierce Healthcare3d
CMS officially names participants in Cell and Gene Therapy Access Model
The Centers for Medicare and Medicaid Services (CMS) has selected 35 participants for its new, voluntary Cell and Gene Therapy Access Model. | As expected, there will be 35 voluntary participants in the CMS' new Cell and Gene Therapy Access Model.
Chinese scientists develop low-cost cell therapy for cancer, asthma and other illnesses
A team of Chinese medical experts say they can produce anti-cancer cells directly inside the human body using gene therapy tools.
Sarepta shares plunge 40% as future of its gene therapy appears at risk
Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk. Sarepta has reported three patient deaths related to its gene therapies.
Pharmabiz1d
Miltenyi Biotec and THSTI FIVE partner to launch India’s first hands-on CAR-T cell and gene therapy training curriculum
Our Bureau, Mumbai Friday, July 18, 2025, 17:45 Hrs [IST]
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