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Home » A first: Biologics dominate 2023 class of accelerated approvals
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A first: Biologics dominate 2023 class of accelerated approvals

March 18, 2024
By Mari Serebrov
At first glance, the number of drugs that received accelerated approval from the U.S. FDA’s Center for Drug Evaluation and Research (CDER) in 2023 was nothing to write home about. Yes, CDER granted nine accelerated approvals last year, up from six in 2022. But the proportion of novel drugs with accelerated approval was 16% both years. And when compared with the 12 drugs in 2020 and the 14 that received accelerated approval in 2021, last year’s crop was a little lackluster. However, a deeper look at the 2023 class of accelerated approvals shows a historic milestone. For the first time since the path was created in 1992, the number of novel biologics getting accelerated approval at CDER outpaced the number of small-molecule drugs.
BioWorld Analysis and data insight Regulatory Neurology/psychiatric U.S. Accelerated review CMS FDA

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