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BioWorld - Saturday, February 21, 2026
Home » Monthly Biopharma Regulatory Analysis

Articles Tagged with ''Monthly Biopharma Regulatory Analysis''

Green approved stamp
Biopharma regulatory actions and approvals February 2025

Global drug approvals hit 47 in February, surpassing 2024 monthly average

March 21, 2025
By Amanda Lanier
The U.S. FDA approved 16 drugs in February, up from 12 in January but still falling short of the 2024 monthly average of 19 approvals. Just two of those were new molecular entities (NMEs), continuing a slower pace compared to the year’s average of slightly more than four NMEs per month.
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FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals January 2025

Astrazeneca, Vertex, Axsome secure US FDA approvals in January

Feb. 25, 2025
By Amanda Lanier
The U.S. FDA approved 12 drugs in January, falling below the 2024 monthly average of 19. Only three new molecular entities received approval, trailing the yearly average of just over four per month.
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FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals January 2025

Astrazeneca, Vertex, Axsome secure US FDA approvals in January

Feb. 21, 2025
By Amanda Lanier
The U.S. FDA approved 12 drugs in January, falling below the 2024 monthly average of 19. Only three new molecular entities received approval, trailing the yearly average of just over four per month.
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FDA approved metal stamp
Biopharma regulatory actions and approvals December 2024

2024 closes with 228 US FDA approvals; December adds 19 drugs

Jan. 23, 2025
By Amanda Lanier
The U.S. FDA approved 19 drugs in December, an increase from 10 in November. In total, 228 FDA approvals were granted in 2024, averaging 19 per month. Seven new molecular entities were approved in December, bringing the year's total to 49.
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FDA Approved stamp
Biopharma regulatory actions and approvals November 2024

Bridgebio’s Attruby FDA nod boosts stock; 10 November approvals

Dec. 23, 2024
By Amanda Lanier
The U.S. FDA approved 10 drugs in November, down from 15 in October, 24 in September and 22 in August. Four new molecular entities were approved by the agency in the month, bringing the year-to-date total to 42.
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FDA Approved seal
Biopharma regulatory actions and approvals October 2024

Two Stelara biosimilars among 15 US FDA approvals in October

Nov. 26, 2024
By Amanda Lanier
The U.S. FDA approved 15 drugs in October, marking a decline from 24 in September and 22 in August. Despite the drop, the 2024 monthly average stands at about 19 approvals, exceeding last year’s average of 16, 2022’s 12.5, and the 17-per-month averages recorded in both 2021 and 2020.
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FDA Approved seal
Biopharma regulatory actions and approvals October 2024

Two Stelara biosimilars among 15 US FDA approvals in October

Nov. 22, 2024
By Amanda Lanier
The U.S. FDA approved 15 drugs in October, marking a decline from 24 in September and 22 in August. Despite the drop, the 2024 monthly average stands at about 19 approvals, exceeding last year’s average of 16, 2022’s 12.5, and the 17-per-month averages recorded in both 2021 and 2020.
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FDA approved metal stamp
Biopharma regulatory actions and approvals September 2024

32 NMEs gain US FDA clearance through Q3, approvals up over 2023

Oct. 18, 2024
By Amanda Lanier
The U.S. FDA approved 23 drugs in September, up from 22 in August and 17 in July, bringing the 2024 monthly average to nearly 20. This surpasses last year's 16 per month, 12.5 in 2022, and 17 per month in both 2021 and 2020.
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Injection syringes
Biopharma regulatory actions and approvals June 2024

Eylea, Neupogen, Stelara biosimilars among 28 FDA nods in June

July 23, 2024
By Amanda Lanier
The U.S. FDA approved 28 new drugs in June, marking the third-highest month in BioWorld’s records, following March 2024’s 30 approvals and June 2020's 29 approvals, and a significant increase from May’s 11 FDA drug approvals. For context, the FDA approved an average of around 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
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Injection syringes
Biopharma regulatory actions and approvals June 2024

Eylea, Neupogen, Stelara biosimilars among 28 FDA nods in June

July 19, 2024
By Amanda Lanier
The U.S. FDA approved 28 new drugs in June, marking the third-highest month in BioWorld’s records, following March 2024’s 30 approvals and June 2020's 29 approvals, and a significant increase from May’s 11 FDA drug approvals. For context, the FDA approved an average of around 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
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