elevidys duchenne muscular dystrophy

News

FDA, Duchenne and Sarepta Therapeutics

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.

· 17h

Parents call on FDA for path forward after Duchenne's gene therapy pause | Morning in America

STAT · 9h

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

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 ...

9hon MSN

Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

Sarepta Therapeutics said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular ...

9hon MSN

FDA recommends lifting voluntary hold on Elevidys in ambulatory patients

The U.S. FDA said on Monday that it recommends lifting the voluntary hold on Sarepta Therapuetics' gene therapy, Elevidys, in ...

Sarepta Therapeutics Stock Soars After FDA Removes Hold On Elevidys For Some Patients

Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) ...

FDA allows Sarepta to resume some Elevidys shipments

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

MIT Technology Review3d

The deadly saga of the controversial gene therapy Elevidys

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

Medical Dialogues1d

Roche gets negative EMA Committee opinion on Elevidys CMA for 3-7 year olds with Duchenne muscular dystrophy

Basel: Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

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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