2022 saw a 25% drop in new drug approvals and a less predictable regulator.
The US Food and Drug Administration (FDA) toughened its stand on Accelerated Approvals and submissions based on China-only data. But it also waved through some drugs despite negative votes or previous rejections, published new plans to speed up access to treatments for rare neurodegenerative diseases, and continues to expand faster approval options (Box 1). The agency also appears to be loosening the reins on cheaper biosimilars.
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Senior, M. Fresh from the biotech pipeline: fewer approvals, but biologics gain share.
Nat Biotechnol (2023). https://doi.org/10.1038/s41587-022-01630-6
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DOI: https://doi.org/10.1038/s41587-022-01630-6
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Melanie Senior