生物制药公司Scholar Rock Holding Corp（SRRK）近日公布，针对其新药上市申请（BLA）的重新提交，公司预期美国食品药品监督管理局（FDA）将在30天内完成受理，并启动正式审查流程。此次审查周期预计最长可达6个月，自重新提交之日起计算。
该公司强调，这一时间表符合FDA对BLA申请的常规处理程序。若审查进展顺利，将为相关创新疗法的后续商业化铺平道路。
生物制药公司Scholar Rock Holding Corp（SRRK）近日公布，针对其新药上市申请（BLA）的重新提交，公司预期美国食品药品监督管理局（FDA）将在30天内完成受理，并启动正式审查流程。此次审查周期预计最长可达6个月，自重新提交之日起计算。
该公司强调，这一时间表符合FDA对BLA申请的常规处理程序。若审查进展顺利，将为相关创新疗法的后续商业化铺平道路。
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