Sarepta Gene Therapy Halt

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Gene therapy, Sarepta

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.

Reuters on MSN · 2h

Sarepta to pause Elevidys gene therapy shipments in US

Sarepta Therapeutics said on Monday it will pause all shipments of Elevidys in the United States after two teenage boys with a rare condition called Duchenne muscular dystrophy, who had received the company's gene therapy,

Devdiscourse · 2h

Sarepta Suspends Gene Therapy Shipments After Tragic Deaths

Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular dystrophy died of liver failure. The suspension follows an FDA request and affects non-ambulatory patients.

MedPage Today11h

Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...

16h

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...

Sarepta tells FDA it won’t halt shipments despite patient deaths

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...

3hon MSN

Sarepta to pause gene therapy Elevidys shipments in US

Sarepta Therapeutics said on Monday that it will pause all shipments of its Elevidys gene therapy in the United States after a muscular dystrophy patient who received a different, experimental ...

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