快速通道指定-话题@MedSci

#快速通道指定#

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快速通道指定

2020-05-29

qidongfanjian (审核中...)

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#快速通道指定#

BTK抑制剂Rilzabrutinib治疗免疫性血小板减少症：被授予FDA快速通道指定

2020-11-21

qidongfanjian (审核中...)

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#快速通道指定#

CD20单抗Ublituximab与PI3K抑制剂Umbralisib联合治疗慢性淋巴细胞白血病，获FDA快速通道指定

2020-10-24

qidongfanjian (审核中...)

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#快速通道指定#

同种异体CAR-T细胞疗法治疗白血病，获得FDA的快速通道指定

2020-08-22

qidongfanjian (审核中...)

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#快速通道指定#

非酒精性脂肪性肝炎新药HM15211，获得FDA快速通道指定

2020-07-19

qidongfanjian (审核中...)

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#快速通道指定#

FDA授予伊立替康脂质体（ONIVYDE）快速通道指定，用于转移性胰腺癌的一线联合治疗

2020-06-19

qidongfanjian (审核中...)

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#快速通道指定#

Orphazyme的热休克蛋白疗法Arimoclomol治疗肌萎缩性侧索硬化症，获得美国快速通道指定

2020-05-24

qidongfanjian (审核中...)

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#快速通道指定#

上周获批II期临床后，Moderna新冠病毒mRNA疫苗又获得FDA授予的快速通道指定

2020-05-15

qidongfanjian (审核中...)

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#快速通道指定#

获得1亿美元融资以及FDA快速通道指定后，荣昌生物再次获得FDA批准——启动抗HER2的ADC药物治疗尿路上皮癌的II期临床试验

2020-05-04

qidongfanjian (审核中...)

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#快速通道指定#

获得1亿美元融资后，荣昌生物的融合蛋白TACI-Fc治疗红斑狼疮获得FDA快速通道指定

2020-04-20

qidongfanjian (审核中...)

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#快速通道指定#

和记黄埔的Surufatinib获得FDA授予快速通道指定，用于治疗胰腺和非胰腺神经内分泌肿瘤

2020-04-20

qidongfanjian (审核中...)

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#快速通道指定#

Alnylam的RNAi疗法Vutrisiran获得FDA快速通道指定，治疗hATTR淀粉样变性

2020-04-17

qidongfanjian (审核中...)

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#快速通道指定#

非阿片类镇痛药EC5026治疗神经性疼痛：获得FDA授予快速通道指定

2020-04-12

qidongfanjian (审核中...)

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#快速通道指定#

FDA授予ADC药物sacituzumab govitecan快速通道指定，用于治疗转移性尿路上皮癌

2020-04-10

qidongfanjian (审核中...)

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#快速通道指定#

Blaze Bioscience的光学成像剂BLZ-100用于"点亮"儿童中枢神经系统肿瘤，获FDA授予快速通道指定

2020-04-10

qidongfanjian (审核中...)

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#快速通道指定#

Agenus的PD-1单抗Balstilimab治疗晚期宫颈癌，获得FDA的快速通道指定

2020-04-10

qidongfanjian (审核中...)

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#快速通道指定#

Agenus的PD-1单抗Balstilimab联合CTLA-4单抗Zalifrelimab治疗晚期宫颈癌，获得FDA的快速通道指定

2020-03-16

qidongfanjian (审核中...)

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#快速通道指定#

Daré Bioscience的克林霉素水凝胶DARE-BV1获得FDA快速通道指定，用于治疗细菌性阴道病

2020-03-14

qidongfanjian (审核中...)

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#快速通道指定#

EHP的大麻双酚衍生物口服制剂EFDA-101治疗系统性硬化症，获得美国FDA的快速通道指定

2020-03-08

qidongfanjian (审核中...)

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#快速通道指定#

Pulmatrix的吸入式抗真菌药Pulmazole获得FDA的快速通道指定，用于治疗哮喘患者的过敏性支气管肺曲霉病

2020-02-03

qidongfanjian (审核中...)

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#快速通道指定#

FDA授予β3-肾上腺素能受体拮抗剂APD418用于代偿性心力衰竭治疗的快速通道指定

2020-01-19

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