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Sarepta says it wont comply with FDA request to stop . . . (Reuters) -U S regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental
Sarepta Refused FDA’s Request to Halt Elevidys Shipments - MSN Sarepta Therapeutics Inc has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, the Food and Drug Administration said Friday
FDA to ask Sarepta to stop shipping Duchenne gene therapy The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive Sarepta last month paused shipments for certain older Duchenne patients following the
Sarepta Craters as FDA Considers Requesting Halt to Elevidys . . . The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a stop to all shipments of the Duchenne muscular dystrophy therapy Elevidys following a third patient death linked to the underlying platform
Report: FDA to Stop Shipments of Gene Therapy - Newsmax Following the death of two teenage boys who received Elevidys, a gene therapy approved in the United States to treat a muscle-wasting condition called Duchenne muscular dystrophy, the FDA will reportedly request Sarepta to stop all shipments