新药申请-话题@MedSci

#新药申请#

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新药申请

2020-05-29

wangbingxhy (审核中...)

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#新药申请#

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

2020-02-23

wangbingxhy (审核中...)

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#新药申请#

Aurinia已完成Voclosporin的FDA新药申请，用于治疗狼疮性肾炎

2021-02-09

wangbingxhy (审核中...)

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#新药申请#

绿叶制药抗抑郁药安舒法辛缓释片LY03005在美国提交新药申请

2020-03-24

wangbingxhy (审核中...)

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#新药申请#

Urovant Sciences宣布提交Vibegron治疗膀胱过度活动症的新药申请

2020-01-13

wangbingxhy (审核中...)

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#新药申请#

君实生物的PD-1单抗特瑞普利治疗尿路上皮癌，补充新药申请被NMPA接受

2021-02-27

wangbingxhy (审核中...)

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#新药申请#

武田制药宣布FDA接受其补充新药申请并给予优先审查，将酪氨酸激酶抑制剂ALUNBRIG用作ALK +转移性非小细胞肺癌的一线治疗

2021-01-24

wangbingxhy (审核中...)

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#新药申请#

膀胱过度活动症的治疗取得新进展！FDA接受Vibegron的新药申请（NDA）

2020-10-12

wangbingxhy (审核中...)

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#新药申请#

非小细胞肺癌及甲状腺癌治疗传喜讯：Selpercatinib的新药申请获得优先审查

2020-04-22

wangbingxhy (审核中...)

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#新药申请#

创伤性脑损伤的治疗：FDA批准了MR-301的研究性新药申请

2019-10-23

wangbingxhy (审核中...)

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#新药申请#

FDA接受葛兰素史克的补充新药申请，将其PARP抑制剂Zejula用作对铂类化疗敏感、晚期卵巢癌患者的一线维持治疗

2020-09-25

wangbingxhy (审核中...)

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#新药申请#

Ponesimod治疗成人多发性硬化症：强生已向美国FDA提交新药申请（NDA）

2020-07-26

wangbingxhy (审核中...)

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#新药申请#

FDA接受ST-001 nanoFenretinide治疗T细胞淋巴瘤的新药申请

2020-07-29

wangbingxhy (审核中...)

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#新药申请#

Intercept向美国FDA提交奥贝胆酸治疗NASH的新药申请

2020-05-26

wangbingxhy (审核中...)

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#新药申请#

FDA接受Lefamulin治疗成人社区获得性细菌性肺炎的新药申请

2019-09-16

wangbingxhy (审核中...)

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#新药申请#

罗沙司他今年有望向FDA递交新药申请，心血管风险成为疑虑

2019-12-17

wangbingxhy (审核中...)

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#新药申请#

Precision宣布FDA批准其靶向CD20的同种异体CAR-T细胞疗法PBCAR20A的研究新药申请IND

2020-01-08

wangbingxhy (审核中...)

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#新药申请#

FDA已接受ONC206的研究性新药申请（IND）

2020-06-21

wangbingxhy (审核中...)

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#新药申请#

Verrica制药宣布FDA批准VP-102的新药申请，用于治疗感染性软疣

2020-08-14

wangbingxhy (审核中...)

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#新药申请#

FDA接受Genentech的XOFLUZA的补充新药申请，用于治疗高危并发症患者的流感

2020-02-19

wangbingxhy (审核中...)

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#新药申请#

Alkermes和Biogen宣布美国FDA接受了Diroximel富马酸盐治疗多发性硬化症的新药申请 

2019-04-15

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