补充新药申请-话题@MedSci

#补充新药申请#

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longId=21572, objectId=b9d4215e217, topicUrl=null, isHasObj=0, objectCover=null, objectUrl=/article/show_article.do?id=b9d4215e217, replyNumber=0, likeNumber=0, createdTime=2014-05-19, rootId=0, userName=TZF0804, userId=0041445, projectId=1, avatar=, status=1, hasArticle=1, attachment=null, ipAttribution=, moduleDTOList=[ModuleDTO(moduleId=b9d4215e217, moduleTitle=FDA接受百时美施贵宝及辉瑞Eliquis补充新药申请（sNDA）, moduleType=article, hrefUrl=https://www.medsci.cn/article/show_article.do?id=b9d4215e217)], followStatus=false, userIsMember=false, type=1, lengthMark=0)] 梅斯话题小助手

补充新药申请

2020-05-29

TZF0804 (审核中...)

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#补充新药申请#

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

2021-09-21

TZF0804 (审核中...)

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#补充新药申请#

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

2021-05-19

TZF0804 (审核中...)

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#补充新药申请#

武田制药宣布FDA接受其补充新药申请并给予优先审查，将酪氨酸激酶抑制剂ALUNBRIG用作ALK +转移性非小细胞肺癌的一线治疗

2020-04-27

TZF0804 (审核中...)

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#补充新药申请#

君实生物的PD-1单抗特瑞普利治疗尿路上皮癌，补充新药申请被NMPA接受

2020-08-09

TZF0804 (审核中...)

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#补充新药申请#

FDA接受葛兰素史克的补充新药申请，将其PARP抑制剂Zejula用作对铂类化疗敏感、晚期卵巢癌患者的一线维持治疗

2020-02-28

TZF0804 (审核中...)

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#补充新药申请#

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

2020-03-27

TZF0804 (审核中...)

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#补充新药申请#

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

2020-07-24

TZF0804 (审核中...)

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#补充新药申请#

FDA批准Heron的补充新药申请以扩大CINVANTI的标签

2019-03-19

TZF0804 (审核中...)

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#补充新药申请#

FDA接受Genentech的XOFLUZA的补充新药申请，用于治疗高危并发症患者的流感

2019-11-13

TZF0804 (审核中...)

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#补充新药申请#

FDA受理安斯泰来新一代前列腺癌口服药物Xtandi补充新药申请

2016-11-04

TZF0804 (审核中...)

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#补充新药申请#

GSK提交药物Promacta的补充新药申请

2014-07-11

TZF0804 (审核中...)

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#补充新药申请#

辉瑞Xeljanz补充新药申请（sNDA）获FDA批准

2014-06-15

TZF0804 (审核中...)

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#补充新药申请#

FDA接受百时美施贵宝及辉瑞Eliquis补充新药申请（sNDA）

2014-05-19

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