FDA 连发多份 CRL,开年大批新药上市申请已遭拒

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2026年以来,全球医药企业就遭遇了FDA的CRL风暴。从罕见病药物到儿童用药,从疗效证据到生产合规,FDA的拒批理由呈现多元化、精细化的特征。近日,Incyte公司收到了FDA发出了一封完整回复函(CRL),拒绝批准其PD-1抑制剂Zynyz联合铂类化疗用于非小细胞肺癌(NSCLC)一线治疗的补充生物制品许可申请(sBLA)。此次申请被拒,与第三方制造商的生产设施检查问题相关——该设施原为...

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