Savara宣布美国FDA受理Molbreevi*治疗自身免疫性肺泡蛋白沉积症的生物制品许可申请

美股速递
Feb 21

Savara Inc(简称Savara)近日宣布,其针对自身免疫性肺泡蛋白沉积症(Autoimmune PAP)的候选药物Molbreevi*的生物制品许可申请(BLA),已正式获得美国食品药品监督管理局(FDA)受理。

这一进展标志着Molbreevi*在监管审批进程中迈出关键一步,为自身免疫性肺泡蛋白沉积症患者带来新的治疗希望。FDA的受理意味着该申请已通过初步审查,并进入实质性审评阶段。

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