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FDA, Sarepta and gene therapy

BioPharma Dive · 1h

FDA asks Sarepta to stop shipping Duchenne gene therapy

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still walk. A pause on shipments to older, non-ambulatory patients remains in place.

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Southwest Journal · 3d

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

Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products

9h

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...

STAT3hOpinion

The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear

The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...

3d

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...

3don MSN

Sarepta shares slump after third patient death this year

Shares of Sarepta Therapeutics declined 17% in early trading on Friday after another patient who had received an experimental ...

NBC4 WCMH-TV on MSN2d

Sarepta Therapeutics lays off 500 employees amid FDA investigation, including 80 in Columbus

Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location.

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