sarepta therapeutics duchenne muscular dystrophy

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FDA, Sarepta Therapeutics and Duchenne

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.

STAT · 6h

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

BioSpace · 5h

FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients

Asianet Newsable on MSN1h

Why Sarepta Therapeutics Stock Surged Nearly 48% In After-Hours Trading Today

The FDA concluded that a recent patient death in Brazil was unrelated to Sarepta’s Elevidys treatment, allowing the company ...

14h

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 ...

Sarepta Therapeutics to Lift Pause on Shipments of Duchenne Treatment Elevidys

Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...

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