Our update for new drug approvals by the US Food and Drug Administration (FDA) in the first half (H1) of 2025 had pointed out how upheavals at the agency had impacted its functioning, with drug approvals dropping by 24 percent.
While the turbulence didn’t subside, approvals picked up considerably in the second half (H2) of 2025. FDA’s Center for Drug Evaluation and Research (CDER) approved 30 new drugs in H2 (as against 16 in H1), taking the total number of approvals for 2025 up to 46. This is an 8 percent drop compared with 50 approvals CDER had granted in 2024.
During the year, CDER saw four new chiefs come and go — Jacqueline Corrigan-Curay (Jan-July 2025), George Tidmarsh (July-Nov 2025), Richard Pazdur (Nov-December 2025) and Tracy Beth Høeg (December 2025-present). In addition, the agency endured thousands of retrenchments. The US Department of Health and Human Services (HHS), under Health Secretary Robert F. Kennedy Jr., enforced funding cuts and changes in approval processes, especially for vaccines.
Overall, we have been witnessing a steady drop in drug approvals by CDER — it approved 55 new drugs in 2023, 50 in 2024 and, 46 in 2025.
Of the 46 new approvals in 2025, 20 were classified as first-in-class (therapies that use a new and unique mechanism of action), out of which 13 were approved in H2 2025. Overall, CDER approved 32 chemical entities and 14 biologics in 2025.
In comparison, approvals by Health Canada and authorizations by the European Medicines Agency (EMA) rose in 2025. The EMA authorized 69 new therapies, up from 64 in 2024. Health Canada approved 46 new therapies in 2025, as compared with 28 in 2024.
FDA’s Center for Biologics Evaluation and Research (CBER) approved 21 biologics in 2025, compared with 13 in 2024, of which eight were notable new drugs.
Interestingly, both CDER and CBER rejected more drugs last year — 43 applications were rejected, including those for new drugs, supplemental filings, generics and biosimilars, as opposed to 29 in 2024.
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