gene therapy duchenne muscular dystrophy

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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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· 1h

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

Facing mounting criticism, Sarepta recently announced plans to add a bold warning label to Elevidys.

· 18h · on MSN

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

· 1d · on MSN

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

· 18h

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...

· 1d

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

· 1d

FDA to ask Sarepta to stop shipping Duchenne gene therapy

STAT1dOpinion

We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress

As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we never asked to join — said goodbye to their sons, the babies they once held in their arms, whose dreams they held in their hearts until Duchenne robbed them of working muscles or a healthy future.

MedPage Today on MSN2d

Duchenne Gene Therapy Will Undergo Changes After Patient Deaths

At the FDA's request, delandistrogene moxeparvovec (Elevidys), the only approved gene therapy for Duchenne muscular dystrophy, will carry a black box warning for acute liver injury and acute liver failure, drugmaker Sarepta Therapeutics said.

1don 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.

STAT1d

Patient dies in Sarepta gene therapy trial, adding to safety concerns

A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to the company's gene therapies

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 with Duchenne MD.