2018 in review: FDA approvals of new molecular entities.

Abstract:

:2018 was a remarkable year, both in terms of the number of new molecular entities (NMEs) approved and the organizations developing them. In total, 59 NMEs received a nod from the US Food and Drug Administration (FDA), most of which were approved using a priority or breakthrough designation. Orphan drugs accounted for more than half of new approvals, only the second time in history that level has been achieved. Moreover, the net number of organizations that received an FDA approval and remain active in new drug research surged in 2018, reflecting both an increase in new organizations and lower levels of industry consolidation.

journal_name

Drug Discov Today

journal_title

Drug discovery today

authors

Kinch MS,Griesenauer RH

doi

10.1016/j.drudis.2019.05.022

subject

Has Abstract

pub_date

2019-09-01 00:00:00

pages

1710-1714

issue

9

eissn

1359-6446

issn

1878-5832

pii

S1359-6446(19)30114-X

journal_volume

24

pub_type

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