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FDA asks Sarepta to stop shipping gene therapy

BioPharma Dive · 2h

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

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

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FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

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Cambridge pharma company lays off almost 500 amid FDA dispute over treatment

A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.

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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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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 ...

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