当地时间3月28日,美国Milestone Pharmaceuticals表示,美国FDA(美国食品药品监督管理局)拒绝批准该公司的一款用于心脏病治疗的鼻喷雾剂,FDA要求对进行该药物测试的设施进行检查。 消息导致Milestone股价暴跌60%。该公司此前预计这款药物将在2025年中期获批上市。 据称,FDA强调了与这款药物相关的两个关键化学问题以及制造和控制流程的问题,但并未对药物本身的...
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