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Sarepta Therapeutics, FDA and Elevidys

· 10h · on 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 Therapeutics' gene therapy Elevidys for patients with a rare muscular disorder who can walk.

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Sarepta will resume gene therapy shipments after FDA review of recent patient death

FDA allows Sarepta to resume some Elevidys shipments

17h

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

The Food and Drug Administration has paused distribution of the gene therapy Elevidys following the death of a third patient ...

Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

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.

Fierce Pharma5d

Roche halts Elevidys distribution in some countries, following Sarepta's lead in US

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

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