FDA Priority Review Drug Approvals

Key insights (2016–2025)

• • Priority Review applies to 61% of all FDA novel drug approvals in this period (278 of 458 drugs).
• • Activity has held roughly steady at ~27/year in 2023–2025 vs 2020–2022. Peak year: 2018 with 43 approvals.
• • 162 unique sponsors received this designation; the top sponsor is Roche (10 approvals). Top 5 sponsors account for 14% of all Priority Review approvals.
• • 65% of Priority Review drugs also received Orphan designation — the most common pairing.