FDA's official announcements and annual drug approval reports

FDA Approves 61 Novel Drugs in 2024, Including Notable Firsts and 19 with Big Clinical Impact

Jan 2, 2025, 02:53 PM

The U.S. Food and Drug Administration (FDA) approved a total of 61 novel drugs in 2024, marking a year that fell short of the record set in 2023 but still exceeded the average annual number of approvals. The FDA's Center for Drug Evaluation and Research cleared 50 new molecular entities, while the biologics center approved 11 novel biologics. The year saw several notable firsts, including the first schizophrenia drug that does not block dopamine receptors, the first drug for non-alcoholic steatohepatitis, the first biparatopic antibody, the first mRNA vaccine not for Covid, and the first TCR-engineered T cell therapy. Additionally, 21% of applications received a complete response letter from the FDA. GoodRx highlighted 19 of these drug approvals as having a big clinical impact.