欧洲药品管理局-话题@MedSci

#欧洲药品管理局#

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欧洲药品管理局

2020-05-29

isabellayj (审核中...)

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#欧洲药品管理局#

Acceleron的TGF-β配体陷阱Sotatercept治疗肺动脉高压，获得欧洲药品管理局的优先药品（PRIME）称号

2020-05-08

isabellayj (审核中...)

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#欧洲药品管理局#

Medivir的MIV-818治疗肝细胞癌，获得欧洲药品管理局对其孤儿药指定的积极评价

2020-05-04

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局：支持诺华的Enerzair Breezhaler三联疗法治疗不受控制的哮喘

2020-05-04

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局：授予MB-107慢病毒基因疗法治疗X连锁严重综合免疫缺陷病的先进疗法分类

2020-04-23

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局（EMA）：允许“同情使用”瑞德西韦（remdesivir）治疗COVID-19

2020-04-06

isabellayj (审核中...)

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#欧洲药品管理局#

基因疗法抗击卵巢癌：欧洲药品管理局授予GEN-1孤儿药认定

2020-03-26

isabellayj (审核中...)

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#欧洲药品管理局#

Myovant Sciences向欧洲药品管理局提交了Relugolix联合片剂治疗子宫肌瘤的上市许可申请

2020-03-12

isabellayj (审核中...)

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#欧洲药品管理局#

Janssen的遗传性视网膜疾病基因疗法AAV-RPGR，获得欧洲药品管理局PRIME称号

2020-03-08

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局CHMP推荐了抗耐药菌药物Fetcroja和抗感染药物Tigecycline上市

2020-03-08

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局接受葛兰素史克的申请，寻求将Trelegy Ellipta三联吸入式疗法用于治疗哮喘

2020-03-04

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局接受GSK靶向BCMA的抗体偶联药物belantamab mafodotin的销售授权申请

2020-02-05

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局的CHMP支持诺和诺德口服GLP-1受体激动剂Rybelsus，用于治疗2型糖尿病

2020-02-04

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局开始审查Kite的自体CAR-T细胞疗法KTE-X19，用于治疗套细胞淋巴瘤

2020-02-04

医者仁心 (审核中...)

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#欧洲药品管理局#

强生的雄激素受体拮抗剂Erleada，获得欧洲药品管理局批准治疗去势敏感型前列腺癌

2020-02-04

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局批准了Seattle Genetics公司的tucatinib用于局部晚期或转移性HER2阳性乳腺癌患者的市场授权申请

2020-02-04

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局（EMA）授予EHP-102治疗亨廷顿氏病的孤儿药资格

2020-02-01

isabellayj (审核中...)

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#欧洲药品管理局#

Abeona Therapeutics的ABO-102基因疗法治疗罕见病，获得欧洲药品管理局的PRIME指定

2019-12-23

isabellayj (审核中...)

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#欧洲药品管理局#

欧洲药品管理局CHMP建议批准7种药物上市和2种药物扩展适应症

2019-11-20

isabellayj (审核中...)

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#欧洲药品管理局#

强生向欧洲药品管理局提交申请，寻求扩大其IL-23单抗Tremfya用于治疗银屑病关节炎

2019-10-25

isabellayj (审核中...)

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#欧洲药品管理局#

安进和优时比的骨质疏松药物Evenity（romosozumab）喜获欧洲药品管理局推荐

2019-10-21

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