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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

The Associated Press on MSN · 7h

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

Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy following the death of a third patient receiving one of its

The Boston Globe · 1d

FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy

The move follows the death of two teenagers who were administered the treatment, as well as the death of a 51-year-old man who received a similar product in a clinical trial for a different form of muscular dystrophy.

BioPharma Dive · 1d

FDA to ask Sarepta to stop shipping Duchenne gene therapy

The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the therapy, Elevidys.

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 ...

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...

Muscular Dystrophy News2d

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 ...

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