Scholar Rock公司今日宣布，美国食品药品监督管理局（FDA）已正式受理其针对Apitegromab用于治疗脊髓性肌萎缩症（SMA）的生物制品许可申请（BLA）。与此同时，该公司正积极推进第二家灌装-封装工厂的建设。市场预期，FDA将在2026年9月30日的行动日期前作出最终审批决定。
Scholar Rock公司今日宣布，美国食品药品监督管理局（FDA）已正式受理其针对Apitegromab用于治疗脊髓性肌萎缩症（SMA）的生物制品许可申请（BLA）。与此同时，该公司正积极推进第二家灌装-封装工厂的建设。市场预期，FDA将在2026年9月30日的行动日期前作出最终审批决定。
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