BioWorld - Saturday, February 21, 2026

Articles Tagged with ''Monthly Biopharma Regulatory Analysis''

Approved stamp
Biopharma approvals January 2026

China tops US in January drug approvals

Feb. 20, 2026
By Amanda Lanier
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U.S. FDA approvals began 2026 at a slower pace than usual, with eight approvals recorded in January. The total falls below the 2025 monthly average of about 19 approvals and trails every month last year, which ranged from 12 to 27 approvals.
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Biopharma regulatory actions and approvals December 2025

US FDA caps 2025 with December high of 27 drug approvals

Jan. 26, 2026
By Amanda Lanier
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The U.S. FDA approved 27 drugs in December, the highest month of 2025. This compares to 18 approvals in November and brings the full year total to 226. This places 2025 just below the 228 approvals recorded in 2024 but well above approval numbers seen in most prior years of the past decade.
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Biopharma regulatory actions and approvals November 2025

Rare diseases drive November’s US drug approvals

Dec. 19, 2025
By Amanda Lanier
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The U.S. FDA approved 18 drugs in November, down from 20 in October, bringing the total number of clearances to 199 through the first 11 months of the year. The number is about 5% lower than the 209 approvals recorded over the same period in 2024 but more than every prior year.
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Biopharma regulatory actions and approvals April 2025

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

May 20, 2025
By Amanda Lanier
No Comments
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.
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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
No Comments
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.
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Vykat XR
Biopharma regulatory actions and approvals March 2025

March FDA approvals beat prior months but NME pace stays slow

April 21, 2025
By Amanda Lanier
The U.S. FDA cleared 21 drugs for market in March, topping 16 approvals granted in February and 12 in January. That brought the first quarter (Q1) total to 49 approvals, just one short of the 50 logged in Q1 2024, making it the second-highest Q1 count in BioWorld’s records.
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