After Deaths and a Pause, Sarepta Restarts ELEVIDYS Shipments After FDA Review Eases Safety Concerns
FDA lifts pause on ELEVIDYS shipments for ambulatory Duchenne patients; therapy targets DMD gene mutations using AAV delivery system. Image source: Shutterstock
Sarepta Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has informed the company that it may lift its pause on shipments of ELEVIDYS (delandistrogene moxeparvovec) for ambulatory patients with Duchenne muscular dystrophy. Sarepta stated it will begin sending ELEVIDYS to treatment centers shortly. The FDA’s decision comes just over a week after … After Deaths and a Pause, Sarepta Restarts ELEVIDYS Shipments After FDA Review Eases Safety Concerns Read More » To access this post, you must purchase Individual Subscriber Yearly or Enterprise Subscriber.
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