gene therapy duchenne muscular dystrophy

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FDA asks Sarepta to stop shipping gene therapy

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request

At the heart of the controversy is a question many patients and families are asking: Should a drug that might save lives also be allowed to risk them?

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

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FDA to ask Sarepta to stop shipping Duchenne gene therapy

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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: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

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Sarepta Therapeutics crisis is huge blow to Duchenne families, company

BioSpace3d

Sarepta Tags DMD Gene Therapy Elevidys With Black Box Warning, Axes 500 Staff

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.

Muscular Dystrophy News3d

Dosing begins in gene therapy trial for DMD-linked heart disease

The first patient has been dosed in a clinical trial testing Sardocor's one-time gene therapy for cardiomyopathy associated with Duchenne MD.