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Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths
The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying the agency was investigating the three deaths due to acute liver failure following treatment with Sarepta's AAVrh74 gene therapies.
Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm behind its approved Duchenne muscular dystrophy (DMD) treatment. | As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head,
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Children's Hospital LA halts use of Sarepta's gene therapy for all patientsChildren's Hospital Los Angeles paused Sarepta's Elevidys gene therapy after FDA flagged safety issues, including deaths in ...
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we ...
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Duchenne Muscular Dystrophy affects 12,000 to 15,000 children and young adults in the United States and about 300,000 worldwide. It's caused by a mutation in the dystrophin gene, which makes a ...
The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...
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