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#

君实生物JS110（XPO1抑制剂）临床试验申请获得美国FDA批准

2022-08-28

10518098zz (审核中...)

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#美国FDA#

儿童活动性狼疮肾炎新选择，美国FDA批准首款儿童生物制剂倍力腾！

2022-08-02

10518098zz (审核中...)

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#美国FDA#

美国FDA受理君实生物重新提交的特瑞普利单抗治疗鼻咽癌上市申请

2022-07-09

10518098zz (审核中...)

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#美国FDA#

美国FDA批准Novavax公司的重组蛋白疫苗NVX-CoV2372，这是美国批准上市的第四款新冠疫苗

2022-06-22

10518098zz (审核中...)

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#美国FDA#

美国FDA顾问小组考虑是否将莫德纳新冠疫苗用于6至17岁人群

2022-06-16

10518098zz (审核中...)

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#美国FDA#

肥厚型心肌病患者新选择！联拓生物合作伙伴百时美施贵宝公司的Camzyos (mavacamten) 获美国FDA批准

2022-04-30

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#美国FDA#

盘点2017-2021年美国FDA批准的抗肿瘤新药

2022-04-27

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#美国FDA#

博生吉靶向B7-H3嵌合抗原受体T细胞注射液获得美国FDA罕见儿科疾病（RPD）认定

2022-04-24

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#美国FDA#

君实生物特瑞普利单抗治疗小细胞肺癌获得美国FDA孤儿药资格认定

2022-04-16

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#美国FDA#

美国FDA或将在本周批准为50岁以上人群接种第四剂mRNA疫苗

2022-03-30

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#美国FDA#

ViiV Healthcare宣布美国FDA已核准用于预防HIV的首个长效针剂Apretude（卡博特韦缓释注射混悬液）

2021-12-25

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#美国FDA#

武田收到美国FDA对TAK-721的完整回应函

2021-12-24

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#美国FDA#

美国FDA扩大镰状细胞病药物Oxbryta的适应症

2021-12-22

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#美国FDA#

2021年12月2日简报：美国FDA批准莫努匹拉韦用于中轻度新冠治疗，奥密克戎蔓延至全球23个国家和地区；我国还有约20%的老年人未接种新冠疫苗

2021-12-03

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#美国FDA#

美国FDA核准BESREMi® (Ropeginterferon α-2b)

2021-11-21

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#美国FDA#

君实生物特瑞普利单抗治疗食管癌获得美国FDA孤儿药资格认定

2021-11-18

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#美国FDA#

美国FDA受理君实生物特瑞普利单抗治疗鼻咽癌的上市申请

2021-11-18

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#美国FDA#

博生吉医药CD7靶向CAR-T细胞注射液获得美国FDA孤儿药资格认定

2021-11-13

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#美国FDA#

美国FDA批准 Cyltezo（阿达木单抗-adbm）作为第一个可与Humira互换的生物仿制药

2021-10-20

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#美国FDA#

康方生物AK120获美国FDA批准特应性皮炎全球Ⅱ期临床试验

2021-09-30

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