News
12d
InvestorsHub on MSNSarepta Shares Drop as FDA Suspends Gene Therapy Trials for Muscular DystrophyShares of Sarepta Therapeutics Inc (NASDAQ:SRPT) plunged 10% after the company disclosed that the U.S. Food and Drug ...
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...
Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was ...
While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), ...
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
11d
Clinical Trials Arena on MSNSarepta refuses to pull gene therapy despite FDA requestSarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.
The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...
15d
Clinical Trials Arena on MSNSarepta share price drops again after third gene therapy deathSarepta Therapeutics’ share price has fallen again following the death of a third patient dosed with its gene therapy treatment. A 51-year-old man with limb-girdle muscular dystrophy (LGMD) type 2D/R3 ...
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
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