FDA就Apitegromab治疗脊髓性肌萎缩症患者发出完整回应信，完全因Catalent Indiana LLC填充完成工厂发现的问题

美股速递2025-09-23

美国食品药品监督管理局就Apitegromab作为脊髓性肌萎缩症患者治疗药物发出了完整回应信，该决定完全基于在Catalent Indiana LLC填充完成工厂识别出的观察结果。

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