Please see the list below for available calendar year reports on New Drug Application (NDA) and Biologic License Application (BLA) approvals.
- NDA and BLA Calendar Year Approvals
New Molecular Entity (NME) Drug and New Biologic Approvals Priority NDA and BLA Approvals Efficacy Supplement Approvals NDA and BLA Approval Times Fast Track Approvals Breakthrough Therapy Approvals
- Accelerated Approvals
Accelerated and restricted approvals under Subpart H (drugs) and Subpart E (biologics)
- Rare Disease and Orphan Drug Designated Approvals