Abstract: In August 2018, US Food and Drug Administration (FDA), European Commission, and Ministry of Health, Labour and Welfare (MHLW) of Japan had totally approved 41 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.