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# 55 Novel Drugs Approved in 2023: Report
- URL: https://www.fdaweb.com/55-novel-drugs-approved-in-2023-report/
- Published: 2024-05-15T12:00:00.000Z
- Updated: 2026-09-14T14:30:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156990

In 2023, CDER approved 55 novel drugs either as new molecular entities through NDAs or new therapeutic biologics under BLAs. The Center’s [*Drug Trials Snapshot Summary Report 2023*](https://www.fda.gov/media/178602/download?attachment&ref=fdaweb.com) says 36% of the novel drugs were first-in-class. Some 53% of the approvals were for the treatment of rare or orphan diseases.

The report also provides information on the percentage of study participants from study sites within the U.S., and for programs that enrolled males and females, the overall percentage of participation by sex is displayed graphically.