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

The FDA said in a statement Friday night that officials met with Sarepta and requested it suspend all sales but “the company refused to do so.”

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

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Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular dystrophy over safety issues, even as patients and investors expressed growing concern about the company’s decision-making.

2don MSN

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.

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.