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BioWorld - Wednesday, June 3, 2026
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Home » US FDA adds five NMEs in August, led by Brinsupri and Modeyso
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Biopharma regulatory actions and approvals August 2025

US FDA adds five NMEs in August, led by Brinsupri and Modeyso

Sep. 19, 2025
By Amanda Lanier
No Comments
The U.S. FDA cleared 18 drugs in August, comparable to July’s 17 but down from June’s 23 approvals. That brings the 2025 U.S. total through August to 143, matching 2020 as the second-highest count on record for BioWorld for the period, after 2024’s high of 159.
BioWorld Analysis and data insight Regulatory U.S. FDA NME

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