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FDA加速审批Lipocine的肌肉萎缩症治疗药物
快速通道计划旨在加速开发和审查治疗严重疾病且存在未满足医疗需求的药物。LPCN 1148获得这一资格后,可以更频繁地与FDA互动,有资格获得加速批准和优先审查,并可能进行新药申请的滚动审查。
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