创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

孙友松. 2018年6月美国和欧盟新批准药物概述[J]. 药学进展, 2018, 42(7): 551-553.
引用本文: 孙友松. 2018年6月美国和欧盟新批准药物概述[J]. 药学进展, 2018, 42(7): 551-553.
SUN Yousong. An Overview of New Drugs Approved in the US and EU in June 2018[J]. Progress in Pharmaceutical Sciences, 2018, 42(7): 551-553.
Citation: SUN Yousong. An Overview of New Drugs Approved in the US and EU in June 2018[J]. Progress in Pharmaceutical Sciences, 2018, 42(7): 551-553.

2018年6月美国和欧盟新批准药物概述

An Overview of New Drugs Approved in the US and EU in June 2018

  • 摘要: 2018年6月,美国和欧盟共批准19个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。

     

    Abstract: In June 2018, US Food and Drug Administration(FDA) and European Commission had totally approved 19 new drugs, including new molecular entities, new active ingredient, new biologics and new line extensions(new indications and new formulations). In this article, new molecular entities, new active ingredients and new biologics receiving their first global approval were analyzed with emphasis on the outcomes of clinical trials and development histories.

     

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