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BioWorld - Sunday, February 15, 2026
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Home » Atzumi and Vanrafia among 3 NMEs approved by US FDA in April
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Biopharma regulatory actions and approvals April 2025

Atzumi and Vanrafia among 3 NMEs approved by US FDA in April

May 19, 2025
By Amanda Lanier
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The U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during the first four months of 2023 and 48 in 2022. Despite the decrease from last year, the 2025 total remains the second-highest in BioWorld’s records for this time frame.
BioWorld Analysis and data insight Regulatory FDA

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