新药申请-话题@MedSci

#新药申请#

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新药申请

2020-05-29

wangbingxhy (审核中...)

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#新药申请#

FDA 受理Momelotinib用于治疗骨髓纤维化的贫血新药申请

2023-01-20

wangbingxhy (审核中...)

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#新药申请#

驯鹿生物与信达生物共同开发的全人源BCMA CAR-T细胞伊基仑赛注射液新药申请上市

2022-07-23

wangbingxhy (审核中...)

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#新药申请#

Solasia宣布在日本提交抗癌药物DARINAPARSIN用于外周T细胞淋巴瘤的新药申请

2021-11-09

wangbingxhy (审核中...)

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#新药申请#

Toripalimab联合化学疗法一线治疗鼻咽癌，中国国家药品监督管理局已批准其补充性新药申请

2021-07-23

wangbingxhy (审核中...)

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#新药申请#

酗酒成瘾新疗法！FDA重新启动针对AD04研究性新药申请的审核

2021-06-02

wangbingxhy (审核中...)

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#新药申请#

中国国家药品监督管理局将优先审查Pamiparib的新药申请

2021-01-15

wangbingxhy (审核中...)

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#新药申请#

FDA接受Alkermes重新提交ALKS 3831治疗精神分裂症的新药申请

2021-05-13

wangbingxhy (审核中...)

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#新药申请#

美国FDA接受BRUKINSA（Zanubrutinib）治疗Waldenström巨球蛋白血症的补充新药申请

2021-03-25

wangbingxhy (审核中...)

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#新药申请#

糖尿病合并低血糖患者的福音！FDA接受dasiglucagon HypoPal“救援笔”用于严重低血糖的新药申请

2021-03-14

wangbingxhy (审核中...)

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#新药申请#

FDA接受了全球早衰症治疗药物Zokinvy的新药申请

2020-10-26

wangbingxhy (审核中...)

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#新药申请#

药品评审中心（CDE）已受理Pamiparib治疗卵巢癌的新药申请

2020-08-03

wangbingxhy (审核中...)

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#新药申请#

免疫球蛋白Octagam治疗严重COVID-19患者：FDA已批准研究性新药申请

2020-05-28

wangbingxhy (审核中...)

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#新药申请#

美国FDA核准武田ICLUSIG® (ponatinib)用于耐药或不耐受慢性期CML成人患者的补充新药申请

2021-09-28

wangbingxhy (审核中...)

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#新药申请#

FDA授予Avacopan治疗ANCA相关性血管炎的新药申请（NDA）

2021-03-04

wangbingxhy (审核中...)

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#新药申请#

FDA接受Karyopharm的口服核出口选择性抑制剂XPOVIO的补充新药申请，用于治疗复发或难治的弥漫性大B细胞淋巴瘤

2020-03-14

wangbingxhy (审核中...)

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#新药申请#

Arimoclomol治疗丙型尼曼-皮克病：已完成新药申请

2020-11-08

wangbingxhy (审核中...)

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#新药申请#

美国FDA批准补充性新药申请（sNDA），扩展MYCAMINE（注射用米卡芬净）的适应症，用于治疗小于4个月大的小儿侵袭性念珠菌血症

2020-07-04

wangbingxhy (审核中...)

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#新药申请#

Astellas在日本提交roxadustat的补充新药申请，用于治疗慢性肾脏疾病相关贫血

2021-01-03

wangbingxhy (审核中...)

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#新药申请#

百济神州PD-1单抗Tislelizumab治疗肝细胞癌的新药申请被NMPA接受，以及Tislelizumab抗肿瘤临床研究汇总

2021-06-02

wangbingxhy (审核中...)

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#新药申请#

免疫激活剂7HP349的研究性新药申请，获得FDA的批准

2020-08-07

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