美国FDA-话题@MedSci

#美国FDA#

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moduleType=article, hrefUrl=https://www.medsci.cn/article/show_article.do?id=19fe1e8806a6)], followStatus=false, userIsMember=false, type=1, lengthMark=0)] 梅斯话题小助手

美国FDA

2020-05-29

10518098zz (审核中...)

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#美国FDA#

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

2020-01-11

10518098zz (审核中...)

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#美国FDA#

多靶标蛋白药物：美国FDA授予MP0250治疗多发性骨髓瘤的孤儿药认定

2020-01-01

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#美国FDA#

FibroGen向美国FDA提交Roxadustat治疗慢性肾病贫血患者的新药申请

2019-12-26

10518098zz (审核中...)

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#美国FDA#

成人埃博拉疫苗获美国FDA批准上市

2019-12-26

10518098zz (审核中...)

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#美国FDA#

美国FDA批准CGRP抑制剂Ubrelvy治疗急性偏头痛

2019-12-26

10518098zz (审核中...)

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#美国FDA#

波士顿科学全球**一次性十二指肠镜EXALT MODEL D获美国FDA批准

2019-12-20

10518098zz (审核中...)

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#美国FDA#

璧辰医药BRAF抑制剂ABM-1310获美国FDA临床试验许可

2019-12-02

10518098zz (审核中...)

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#美国FDA#

美国FDA批准了日本盐野义制药的Fetroja，用于复杂尿路感染患者

2019-11-19

10518098zz (审核中...)

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#美国FDA#

1448万一支！史上昂贵药遭美国FDA叫停

2019-11-16

10518098zz (审核中...)

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#美国FDA#

美国FDA批准Zejula（niraparib）用于复发性卵巢癌妇女的晚期治疗

2019-10-25

10518098zz (审核中...)

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#美国FDA#

大逆转，曾终止临床三期的AD药物aducanumab将申请上市昨日（10月22日），渤健（Biogen）和卫材（Eisai）联合宣布，在与美国FDA沟通后，渤健

2019-10-25

医者仁心 (审核中...)

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#美国FDA#

强生Zejula获美国FDA突破性药物资格中国大陆已进入优先审查！

2019-10-11

10518098zz (审核中...)

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#美国FDA#

上海医工院为何拒绝美国FDA检查，全新官方声明来了

2019-10-10

10518098zz (审核中...)

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#美国FDA#

Intercept向美国FDA提交奥贝胆酸治疗NASH的新药申请

2019-10-01

10518098zz (审核中...)

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#美国FDA#

美国FDA批准CD38单抗Darzalex联合疗法，用于可移植的多发性骨髓瘤

2019-09-29

10518098zz (审核中...)

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#美国FDA#

根据与澳大利亚加拿大的新同步审查计划，美国FDA批准Keytruda与乐伐替尼组合治疗子宫内膜癌

2019-09-20

10518098zz (审核中...)

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#美国FDA#

美国FDA授予Nomacopan治疗大疱性类天疱疮的孤儿药物指定

2019-09-17

10518098zz (审核中...)

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#美国FDA#

美国FDA已批准抗体-药物偶联物（ADC）OBI-999的IND

2019-09-06

10518098zz (审核中...)

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#美国FDA#

骨髓增生异常综合征的治疗：ASTX727已获美国FDA的孤儿药物指定

2019-09-06

10518098zz (审核中...)

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#美国FDA#

美国FDA授予Nangibotide治疗感染性休克的快速通道资格

2019-09-06

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