FDA Accelerated Approval Drug Approvals

Key insights (2016–2025)

• • Accelerated Approval applies to 17% of all FDA novel drug approvals in this period (80 of 458 drugs).
• • Activity has held roughly steady at ~9/year in 2023–2025 vs 2020–2022. Peak year: 2021 with 13 approvals.
• • 56 unique sponsors received this designation; the top sponsor is Roche (5 approvals). Top 5 sponsors account for 24% of all Accelerated Approval approvals.
• • 96% of Accelerated Approval drugs also received Priority Review designation — the most common pairing.