FDA drug approvals rebound above decade average in 2025, says GlobalData

18 June 2026

The US Food and Drug Administration (FDA) approved 131 drugs across new drug application (NDA), biologics license application (BLA), and biosimilar pathways in 2025, a 4.8% rise from the previous year, according to a new report from data and analytics firm GlobalData.

This report, New Drug Approvals and Their Contract Manufacture: 2026 Edition, said approvals were above the 2016 to 2025 annual average of 123 products, suggesting a recovery after years of fluctuation in regulatory output.

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