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#

慢性自发性荨麻疹(CSU)新药！诺华新一代IgE抗体ligelizumab获美国FDA突破性药物资格!

2021-01-18

10518098zz (审核中...)

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#美国FDA#

Chi-Med公司开始向美国FDA递交Surufatinib治疗晚期神经内分泌肿瘤的申请

2020-12-31

10518098zz (审核中...)

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#美国FDA#

LORBRENA（lorlatinib）治疗先前未经治疗的ALK阳性肺癌的sNDA已被美国FDA接受优先审查

2020-12-31

10518098zz (审核中...)

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#美国FDA#

双特异性抗体KN026与KN046联合疗法获美国FDA孤儿药资格认定，用于治疗胃癌及胃食管连接部癌

2020-12-25

10518098zz (审核中...)

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#美国FDA#

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

2020-12-25

10518098zz (审核中...)

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#美国FDA#

美国FDA延迟批准诺华的siRNA药物inclisiran

2020-12-21

10518098zz (审核中...)

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#美国FDA#

美国FDA批准转基因猪，推进医疗用途的异种移植

2020-12-18

10518098zz (审核中...)

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#美国FDA#

创新靶向药RET抑制剂Pralsetinib扩展适应症获美国FDA批准，用于治疗甲状腺癌

2020-12-04

10518098zz (审核中...)

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#美国FDA#

AB201作为COVID-19的潜在疗法：已获美国FDA快速通道认证

2020-11-26

10518098zz (审核中...)

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#美国FDA#

新冠大流行转折点？辉瑞，BioNTech正式向美国FDA提交申请以批准新冠疫苗

2020-11-22

10518098zz (审核中...)

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#美国FDA#

诺诚健华奥布替尼获美国FDA批准开展治疗多发性硬化症临床II期研究

2020-11-07

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#美国FDA#

FXR激动剂ASC42治疗NASH：美国FDA已批准IND

2020-10-14

10518098zz (审核中...)

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#美国FDA#

美国FDA批准欧狄沃联合伊匹木单抗用于既往未经治疗的、不可切除的恶性胸膜间皮瘤患者，成为且目前**获批的免疫疗法

2020-10-11

10518098zz (审核中...)

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#美国FDA#

美国FDA批准欧狄沃®（纳武利尤单抗）联合伊匹木单抗成为且目前**获批的免疫疗法，用于既往未经治疗的、不可切除的恶性胸膜间皮瘤患者

2020-10-11

10518098zz (审核中...)

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#美国FDA#

Evinacumab治疗纯合型家族性高胆固醇血症(HoFH)：美国FDA已接受生物许可申请（BLA）

2020-08-15

10518098zz (审核中...)

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#美国FDA#

miR-155抑制剂治疗T细胞淋巴瘤，获得美国FDA的孤儿药物指定

2020-07-26

10518098zz (审核中...)

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#美国FDA#

Fruquintinib治疗转移性结直肠癌：美国FDA授予快速通道称号

2020-06-20

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#美国FDA#

关注罕见病“真性红细胞增多症”：PTG-300获美国FDA孤儿药物认定

2020-06-20

10518098zz (审核中...)

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#美国FDA#

肺癌一线免疫治疗！BMS明星免疫组合Opdivo+Yervoy获美国FDA批准第5个适应症，治疗转移性非小细胞肺癌患者!

2020-05-20

10518098zz (审核中...)

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#美国FDA#

瑞德西韦获得美国FDA紧急使用授权，但医生在用药时面临难题

2020-05-19

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