NDA and BLA Approvals
Please see the list below for available calendar year reports on New Drug Application (NDA) and Biologic License Application (BLA) approvals.
Reports
- 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
- Animal Rule Approvals
- Rare Disease and Orphan Drug Designated Approvals