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2022 FDA approvals

The FDA approved 37 novel drugs in 2022, the fewest to pass regulatory scrutiny since 2016.
  1. Asher Mullard
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Last year the FDA’s Center for Drug Evaluation and Research (CDER) approved 37 novel drugs. This is a drop from the highs of the past 5 years, and brings the rolling 5-year average down to 49 drugs per year. But the 2022 approval number remains above the historic average since 1993, of 34 drugs per year (Fig. 1, Table 1).

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Nature Reviews Drug Discovery 22, 83-88 (2023)

doi: https://doi.org/10.1038/d41573-023-00001-3

Updates & Corrections

  • Update 16 January 2023: Information on the financial performance of the new drugs approved and the characteristics of the reviews by the FDA has been added to the article, with an additional column in Table 1 and Figure 4.

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