2019年7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 July 2019

2019年7月,美国和欧盟共批准14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。

In July 2019, US Food and Drug Administration(FDA) and European Commission had totally approved 14 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.