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DBV Technologies宣布FDA接受Viaskin治疗花生过敏的BLA申报

2019-10-05 Allan MedSci原创

FDADBV花生过敏
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临床阶段生物制药公司DBV Technologies近日宣布，美国FDA已接受Viaskin®花生免疫疗法治疗4至11岁的花生过敏儿童的BLA（Biologics License Application）。

临床阶段生物制药公司DBV Technologies近日宣布，美国FDA已接受Viaskin®花生免疫疗法治疗4至11岁的花生过敏儿童的BLA（Biologics License Application）。Viaskin®花生免疫疗法是DBV Technologies的主要候选产品，旨在减少由于意外接触花生而危及生命的过敏反应。Viaskin®花生免疫疗法是一种非侵入性的，每天一次的表皮贴剂，旨在递送微克量的花生抗原来激活免疫系统。

DBV Technologies首席执行官Daniel Tassé表示：“FDA接受Viaskin®的BLA是有意义的一步。我们期待与FDA继续合作，有可能在2020年下半年将Viaskin®花生免疫疗法带给患者”。


原始出处：

http://www.firstwordpharma.com/node/1671813#axzz61Rlned4y

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    2019-12-10 1508842480_96220446

    #申报#

    0

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    2020-08-13 shock_melon

    #TEC#

    0

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    2019-10-15 仁医06

    #DBV#

    0

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    2019-10-11 Dr Z

    学习了

    0

  5. 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    2019-10-08 1ddf0692m34(暂无匿称)

    学习了，长知识

    0

  6. 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    2019-10-08 飛歌

    学习了很有用不错

    0

  7. 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objectType=article, channel=null, level=null, likeNumber=125, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86936, encryptionId=43b7869368a, topicName=花生过敏)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e1079863863, createdName=xfpan15, createdTime=Mon Oct 07 02:51:00 CST 2019, time=2019-10-07, status=1, ipAttribution=)]
    2019-10-07 1209e435m98(暂无昵称)

    学习了，谢谢分享

    0

  8. 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objectType=article, channel=null, level=null, likeNumber=125, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86936, encryptionId=43b7869368a, topicName=花生过敏)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e1079863863, createdName=xfpan15, createdTime=Mon Oct 07 02:51:00 CST 2019, time=2019-10-07, status=1, ipAttribution=)]
    2019-10-07 深海的鱼

    学习学习学习

    0

  9. 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    2019-10-07 yjs木玉

    好好好好好好

    0

  10. 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    2019-10-07 xfpan15

    #花生过敏#

    0

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20年首次突破！FDA批准卡格列净治疗“糖尿病肾病”适应症！

2019年9月30日，美国食品药品监督管理局（FDA）批准了卡格列净（怡可安®）肾病获益适应症：卡格列净用于降低糖尿病肾病患者的终末期肾病、肾功能恶化、心血管死亡以及心衰住院风险。这使卡格列净成为近20年来首个且唯一一个在糖尿病肾病患者中延缓肾病进展同时降低心衰住院风险的降糖药。

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