Regulatory Action – Talk Bio

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Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

2 days ago talkbio0Tagged ELEVIDYS, gene therapy, lack of transparency, Market, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, United States Food and Drug Administration, Withdraw (activity)

Sarepta Therapeutics; Elevidys; patient deaths; FDA; lack of transparency; gene therapy; market withdrawal; regulatory action; limb-girdle muscular dystrophy (LGMD); Duchenne muscular dystrophy

Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments

4 days ago talkbio0Tagged AAVrh74, CHARGE Syndrome, drug safety, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, Ships, Suspensions, United States Food and Drug Administration

Sarepta; Elevidys; FDA; HHS; gene therapy; Duchenne muscular dystrophy; drug safety; shipping suspension; patient deaths; AAVrh74; regulatory action