2023 FDA approvals

The FDA approved 55 novel therapeutics in 2023, the second highest count in the past 30 years.

NEWS 02 January 2024 Update 22 January 2024 Correction 22 March 2024 2023 FDA approvals The FDA approved 55 novel therapeutics in 2023, the second highest count in the past 30 years. By Asher Mullard Twitter Facebook Email The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023, as the small molecule and biologic pharmacopoeia continues to grow. This cohort is nearly 50% bigger than the new approval class of 2022, which fell below the approval trend line. The ten-year rolling average for new CDER approvals now stands at 46 per year, the highest it has been in over 20 years. The nadir was 2010, when this average bottomed out at 25 per year.