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FDA partially lifts hold on Sarepta's Duchenne gene therapy

FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt

The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular dystrophy to some patients.

Fierce Pharma · 9h

FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just 10 days after the agency requested that the company halt all shipments of the one-time treatment following reports of three deaths among patients who had received a Sarepta gene therapy, including two on Elevidys.

The Business Journals · 10h

FDA partially lifts hold on Sarepta's Duchenne gene therapy after community outcry

The FDA has partially reversed course on its push to halt shipments of a controversial gene therapy made by Sarepta Therapeutics.

10hon MSN

US FDA recommends removal of hold on Sarepta's Elevidys in some patients

The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...

18h

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

17hon MSN

Sarepta Stock Rises Despite Downgrade and FDA Probe. The Crisis Explained.

Sarepta shares gained even though the U.S. Food and Drug Administration said late Friday that it was probing the death of an ...

News Nation on MSN15h

Parents urge FDA to restore gene therapy after distribution pause

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

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