FDA Drug Approvals in 2025 Remain Within Recent Averages Amid Agency Upheaval
In the first three quarters of 2025, the FDA approved an average number of new drugs, with 28 approvals counted by late August1.
Jefferies analysts project a total of 43 new drug approvals by the end of 2025, which is consistent with the recent five-year range (37–68 approvals annually)1.
Despite significant disruptions at the FDA—including major leadership changes, staff reductions, and a gene therapy safety controversy—the approval pace remains stable and not significantly lower than previous years1.
The number of Complete Response Letters (CRLs, i.e., rejections) issued by CDER in 2025 is trending lower than in past five years, while CBER’s CRL rate is elevated1.
2024 saw 50 new drug approvals by CDER, and 2022 had a notable dip with only 37 approvals, the lowest since 201646.
Quarterly analysis showed 7 novel drug approvals in Q1 2025 and 9 in Q2 2025, both considered within or just below the typical range for recent years9.
Sources:
1. https://www.biospace.com/fda/consistency-in-the-chaos-fda-approvals-within-average-range-as-q4-kicks-off
4. https://www.dcatvci.org/features/new-drug-approvals-in-2024-how-did-the-industry-fare/
6. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2022