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# FDA 2023 Novel Drug Approvals Up
- URL: https://www.fdaweb.com/fda-2023-novel-drug-approvals-up/
- Published: 2024-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:19:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156064

FDA approval of novel drugs was up about 50% in 2023 over 2022, keeping pace with historical levels. An agency [announcement](https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023?ref=fdaweb.com) lists 55 new drugs and biologics approved in 2023.

Some of these products have never been used in clinical practice, FDA says. The listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that CBER approved in 2023\. The announcement says some of the products are the same as, or related to, previously approved products, and will compete with those products in the marketplace.

In an [analysis](https://www.nature.com/articles/d41573-024-00001-x?ref=fdaweb.com) of the approvals, *Nature* says the 10-year rolling average for CDER approvals is 46 per year, the highest it has been in 10 years. The article also includes selected CBER approvals for 2023.

By therapeutic area, *Nature* says, oncology continues to get the most approvals, with 13 new cancer therapies approved last year. Neurology was second, with nine approvals. Infectious diseases and hematology tied for third place with five apiece.