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In this section: Drug and Biologic Approval and IND Activity Reports

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

Resources

Monthly Drug Approval Reports in Drugs@FDA

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