欢迎关注凯莱英药闻 国内NDA汇总1、君实生物：昂戈瑞西单抗注射液作用机制：抗PCSK9单克隆抗体适应症：高胆固醇血症、高脂血症4月26日，NMPA已 ...

新药上市获批 NDA 1、勃林格殷格翰：佩索利单抗注射液 作用机制：靶向IL-36R抗体 适应症：泛发性脓疱型银屑病 3月6日，勃林格殷格翰的佩索利单抗 ...

主题： 准备NDA/BLA时的重要考量 主讲人： 陈伟 先生 康德弘翼执行主任、法规事务部负责人 李小贝 女士 康德弘翼临床统计编程高级经理 ...

DUBLIN, Sept. 17, 2018 /PRNewswire/ -- The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada " conference has been added to ResearchAndMarkets.com's offering.

Dublin, Oct. 16, 2019 (GLOBE NEWSWIRE) -- The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering.

Contacts ResearchAndMarkets.com Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office ...

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (Newark, NJ, United States - November 8th-9th, 2018) - ResearchAndMarkets.com ...

An Abbreviated New Drug Application (ANDA) is a written request to the U.S. Food and Drug Administration to manufacture and market a generic drug in the United States.

Specifically, NDA/ANDA holders are required to review information about their products in the current edition of Orange Book and then submit the one-time Marketing Status Report, in writing, to ...

--NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, today announced the transmission of its Abbreviated New Drug Application for electronic filing to the U.S. Food and Drug ...