国家药监局批准2款创新药上市

南方财经网
6 hours ago

南方财经8月12日电,近日,国家药品监督管理局通过优先审评审批程序,附条件批准药捷安康(南京)科技股份有限公司申报的1类创新药替恩戈替尼片(商品名称:捷恩泰)上市,该药用于既往接受过系统性治疗和FGFR抑制剂治疗,且具有成纤维细胞生长因子受体(FGFR)2融合或重排的晚期、转移性或不可手术切除的胆管癌成人患者的治疗。该药品上市为患者提供了新的治疗选择。近日,国家药品监督管理局批准济川药业集团...

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