FDA to Review 16 Drug Applications Including 8 New Molecular Entities by Year-End

The U.S. Food and Drug Administration (FDA) is scheduled to review 16 Prescription Drug User Fee Act (PDUFA) dates before the end of the year, according to publicly available information. Among these reviews, eight involve potential new molecular entities (NMEs), which could contribute to the annual count of newly approved drugs. PDUFA dates are deadlines by which the FDA must decide on drug approval applications submitted by pharmaceutical companies.

These upcoming decisions represent opportunities for advancements in drug development and regulatory approvals as the year concludes. NMEs typically signify innovative treatments that have not been previously approved in any form, highlighting their importance in addressing unmet medical needs. The remaining eight PDUFA dates pertain to supplemental applications or other types of submissions seeking expanded indications or modifications to existing products.

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Date: December 2, 2025

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