FDA Drug Approvals by Year & by FDA Commissioner

CDER novel drug approvals by year

Year · count · FDA Commissioner

By FDA leadership era

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 694-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.

FAQ