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Sarepta, FDA and Gene Therapy

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

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments.

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BioPharma Dive · 5d

FDA asks Sarepta to stop shipping Duchenne gene therapy

Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys

5d

Sarepta Stock Keeps Sliding as Company Rejects FDA Call to Withdraw Drug

Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug ...

8d

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...

Recapping the Sarepta Saga—And Implications for Industry

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential ...

In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.

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