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Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.
Sarepta pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the fourth quarter.
Sarepta Therapeutics refused a FDA request to halt shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy ...
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Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...
FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...
A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
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