2020 in review: FDA approvals of new medicines

Michael S. Kinch, Zachary Kraft, Tyler Schwartz

Research output: Contribution to journalShort surveypeer-review

3 Scopus citations


Amid a global pandemic, the US Food and Drug Administration (FDA) remained relatively active, approving 55novel molecular entities (NMEs) in 2020, the third highest annual rate recorded. Orphan approvals also surged, capturing 60% of NMEs introduced during 2020, as did the number of NMEs approved using a priority review. The pandemic did appear to impact one recent trend, and in a paradoxically encouraging way. Escalating rates of consolidation slowed in 2020, with only 102 companies lost, down by two-thirds over the rate in 2019. This leaves 2000 extant clinical-stage pharmaceutical companies. When limiting this analysis to companies contributing to the research and development (R&D) of an approved drug, eight were lost, leaving 144 extant.

Original languageEnglish
Pages (from-to)2794-2799
Number of pages6
JournalDrug Discovery Today
Issue number12
StatePublished - Dec 2021


  • Drug discovery
  • FDA
  • New molecular entities


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