(来源:一度医药)转自:一度医药2025年9月23日,医药行业迎来了一则重磅消息:FDA正式拒绝批准Scholar Rock公司的在研肌抑素抑制剂apitegromab用于治疗脊髓性肌萎缩症(SMA)。这一决定并非因为药物本身的疗效或安全性问题,而是由于一家第三方制造商的生产场地隐患。这一事件再次将该长期深陷争议的生产场地推到了行业的风口浪尖。根据FDA的拒批函,问题出在Catalent印第安纳...
Source Link(来源:一度医药)转自:一度医药2025年9月23日,医药行业迎来了一则重磅消息:FDA正式拒绝批准Scholar Rock公司的在研肌抑素抑制剂apitegromab用于治疗脊髓性肌萎缩症(SMA)。这一决定并非因为药物本身的疗效或安全性问题,而是由于一家第三方制造商的生产场地隐患。这一事件再次将该长期深陷争议的生产场地推到了行业的风口浪尖。根据FDA的拒批函,问题出在Catalent印第安纳...
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