美国FDA-话题@MedSci

#美国FDA#

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美国FDA

2020-05-29

10518098zz (审核中...)

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#美国FDA#

亚盛医药alrizomadlin（APG-115）治疗黑色素瘤获美国FDA快速通道资格

2021-09-25

10518098zz (审核中...)

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#美国FDA#

JAMA子刊：500万人数据，美国FDA证实“宝藏药”沙库巴曲-缬沙坦真的有效！

2021-09-24

10518098zz (审核中...)

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#美国FDA#

武田的EXKIVITY™ (mobocertinib)成为美国FDA首次核准的专为EGFR外显子20插入+ NSCLC患者设计的口服治疗药物

2021-09-24

10518098zz (审核中...)

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#美国FDA#

2021年9月19日简报：福建4地新增31例确诊病例；国药灭活疫苗在儿童中效果良好；美国FDA否决辉瑞新冠疫苗加强针计划

2021-09-20

10518098zz (审核中...)

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#美国FDA#

内幕消息 - 美国FDA批准百济神州:百悦泽用于治疗华氏巨球蛋白血症患者

2021-09-04

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#美国FDA#

君实生物完成向美国FDA滚动提交特瑞普利单抗治疗鼻咽癌的上市申请

2021-09-03

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#美国FDA#

美国FDA全面批准辉瑞BioNTech新冠mRNA疫苗，美军将全员接种

2021-08-26

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#美国FDA#

KRAS抑制剂获美国FDA加速批准，治疗非小细胞肺癌

2021-06-02

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#美国FDA#

美国FDA批准辉瑞/BioNTech新冠疫苗用于12-15岁青少年

2021-05-13

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#美国FDA#

武田宣布美国FDA将优先审理Mobocertinib (TAK-788)治疗EGFR外显子20插入+转移性非小细胞肺癌的新药报批

2021-05-01

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#美国FDA#

安进创新胃癌一线疗法bemarituzumab获美国FDA突破性疗法认定

2021-04-23

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#美国FDA#

全球首创！康方生物PD-1/CTLA-4双抗治疗宫颈癌获美国FDA孤儿药认定

2021-02-28

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#美国FDA#

蜱传脑炎疫苗TicoVac，已获得美国FDA的优先审查

2021-02-26

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#美国FDA#

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

2021-02-20

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#美国FDA#

美国FDA批准PANZYGA治疗成人慢性炎性脱髓鞘性多发性神经病（CIDP）

2021-02-16

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#美国FDA#

美国FDA宣布：全球第4款CAR-T细胞疗法获批上市，治疗复发性或难治性大B细胞淋巴瘤，安全性更高！

2021-02-09

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#美国FDA#

美国FDA授予Bcl-2抑制剂APG-2575第五个孤儿药称号，用以治疗滤泡性淋巴瘤（FL）

2021-02-02

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#美国FDA#

甘李药业的候选药物GLR2007已获得美国FDA“快速通道资格”

2021-02-02

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#美国FDA#

友芝友生物PD-L1/TGF-β双特异性抗体新药获得美国FDA临床试验批准

2021-01-25

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#美国FDA#

美国FDA批准阿斯利康和第一三共制药的Enhertu用于胃腺癌

2021-01-20

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