Breakthrough Therapy Approvals
The CDER Breakthrough Therapy (BT) Approvals reports contain a list of approvals for breakthrough therapy designated drugs. New reports will be published quarterly for the current calendar year (CY).
Approvals
- Current CY CDER BT Approvals (as of December 31, 2025) (PDF - 105 KB)
- Previous Cumulative CY CDER BT Approvals (PDF - 304 KB)