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Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
摘要:美国 FDA 在短短三天内完成监管态度的 180 度转变 —— 先因一名 8 岁巴西患者死亡启动调查,随即认定死因与 Sarepta 的基因疗法 Elevidys 无关,建议解除针对可行走患者的自愿暂停令。这一反转不仅让 Elevidys ...
In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...
Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, ...
2025年7月18日,FDA发布声明,要求Sarepta立即自愿停止Elevidys的全部商业供应。此前公司已主动停止对非行走患者的供药,但依然持续为尚能行走的患儿供药。面对FDA的请求,Sarepta选择拒绝,理由是“行走人群中并无新增或变化的安全 ...
Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook.
Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...
Sarepta Therapeutics (SRPT) stock in focus as report says company hired a Trump-linked lobbying firm after deaths linked to ...
Sarepta Therapeutics Inc.’s shares soared after the US biotech reported revenue that beat estimates, which analysts ...
After a second Elevidys patient death from acute liver failure, Sarepta in July launched a major restructuring that involves ...
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
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