How many novel drugs the FDA (CDER) approved each year since 2020, which Commissioner led each era, and what it means for biotech catalyst traders. Facts and official counts: never approval predictions.
Our own number: first-cycle approval rate
73.5%
first-cycle approval: our universe, n=1,888
75-81%
FDA’s own PDUFA performance reports
The gap is real, and it’s the honest part. Our rate is a few points below the FDA’s, and that is exactly what you should expect: our universe is publicly-traded biotech, smaller sponsors, first-in-class assets, thinner CMC and clinical-operations budgets. The FDA’s figure covers all NDAs and BLAs, including big-pharma supplements that are far easier to get through on the first pass.
We publish both numbers rather than the flattering one. If our figure had matched the FDA’s exactly, that would have been the suspicious result.
Sources: FDA PDUFA Performance Reports and Independent Evaluation of FDA’s First-Cycle Review Performance. Our figure: 1,888 FDA decisions on listed biotechs. Historical base rate, not a probability for any individual drug (why we don’t do those).
CDER novel drug approvals by year
Source: FDA CDER Novel Drug Approvals annual reports. "Novel" = new molecular entities & new therapeutic biologics; it excludes most sNDAs, generics and biosimilars, so it undercounts total FDA decisions.
Year · count · FDA Commissioner
2020 · Stephen Hahn53 novel drugs
2021 · Janet Woodcock (Acting)50 novel drugs
2022 · Robert Califf37 novel drugs
2023 · Robert Califf55 novel drugs
2024 · Robert Califf50 novel drugs
2025 · Marty Makary46 novel drugs
By FDA leadership era
Stephen Hahn (2019-Jan 2021)2020: 53
Janet Woodcock, Acting (2021-Feb 2022)2021: 50
Robert Califf (Feb 2022-Jan 2025)2022-24: 37 / 55 / 50
Marty Makary (2025-May 2026)2025: 46
Kyle Diamantas, Acting (May 2026: )2026: in progress
The 2025-26 FDA leadership upheaval
FDA leadership has turned over at an unprecedented rate. Robert Califf departed in January 2025; Marty Makary served as Commissioner from 2025 until May 2026; Kyle Diamantas became Acting Commissioner in May 2026. The drug center (CDER) itself cycled through multiple acting directors in 2026, industry reporting described several CDER heads within a single year. For catalyst watchers this matters because review priorities, complete-response-letter posture, and timelines can shift with leadership. Leadership is volatile: always verify the current officials at fda.gov.
What it means for FDA-catalyst traders
Approval counts are only part of the picture. In our tracked PDUFA dataset, the share of decisions ending in approval (vs a Complete Response Letter) ran about 70-74% in 2024-26, but note that many CRLs are never press-released, so the true approval rate is lower than any dataset that only counts announced CRLs. More useful than a single number is the decision-day reaction by company size: in our 763-PDUFA cohort, median absolute move on the decision was roughly ±7% for micro-caps, ±3% small, ±2% mid, ±1% large. These are historical base rates, not predictions for any one drug.