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BioWorld - Sunday, January 18, 2026
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Home » US FDA approvals up 16% over last year
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Biopharma regulatory actions and approvals August 2023

US FDA approvals up 16% over last year

Sep. 22, 2023
By Amanda Lanier
Approvals from the U.S. FDA are up more than 16% from last year, with 113 drugs approved in the first eight months of 2023. New approvals include two different treatments for relapsed or refractory multiple myeloma, two treatments for ultra-rare diseases and a biosimilar to Biogen Inc.’s Tysabri. In August the FDA greenlighted 13 drugs, approving three NDAs, six BLAs, two supplemental NDAs and two supplemental BLAs.
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