U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process (Drugs)
  4. How Drugs are Developed and Approved
  5. Drug and Biologic Approval and IND Activity Reports
  6. NDA and BLA Approvals
  7. Breakthrough Therapy Approvals
  1. Drug and Biologic Approval and IND Activity Reports

Breakthrough Therapy Approvals

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

Related Information