Sarepta Duchenne Community Response

News

Sarepta, FDA and Duchenne

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

STAT · 1d

Roche halts some shipments of Sarepta’s Duchenne gene therapy outside U.S.

Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid safety concerns.

Southwest Journal · 6d

Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy

Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% as company halts non-ambulatory patient treatments.

BioSpace2d

Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

MedCity News5y

Documents give inside view of FDA's rejection, and surprise approval ...

The company, Cambridge, Massachusetts-based Sarepta Therapeutics, had initially received a complete response letter – or CRL, essentially an FDA notice of rejection – in August for the drug ...

Devdiscourse2d

Health and Innovation: Elderly Fitness, Corporate Battles, and Medical Advances

Recent developments in the health sector include fitness classes helping Ugandan women fight noncommunicable diseases, Humana's legal challenge to US Medicare star ratings downgrades, Sarepta pausing ...

BioSpace2d

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...

Yahoo1mon

Second Duchenne patient dies after receiving Sarepta gene therapy - Yahoo

A second person with Duchenne muscular dystrophy has died after receiving a gene therapy from Sarepta Therapeutics, leading the company to stop treating certain patients with the medicine, known ...

Nasdaq2y

Sarepta Therapeutics Announces Recipients of Route 79, The Duchenne ...

--Sarepta Therapeutics, Inc., the leader in precision genetic medicine for rare diseases, today announced twenty recipients of Route 79, The Duchenne Scholarship Program for the 2022-2023 academic ...

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