A year in pharmacology : new drugs approved by the US Food and Drug Administration in 2024

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Description of rights: CC-BY-4.0
Item type:Item, ZeitschriftenaufsatzAccess status: Open Access ,

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The US Food and Drug Administration approved 50 new drugs and nine new cellular and gene therapy products in 2024, i.e., a total of 59 new medical therapies. The latter group represented three treatments each for oncology and hematology/immunotherapy, and one each for neurology, genetic disorders, and cardiovascular disorders. Oncology, hematology/immunotherapy, and neurological disorders (14, six, and seven, respectively) also were highly prevalent among classic medications. Looking at trends over the past 5 years, we observe a greater share in first-in-class medications, more fast-track approvals, and mRNA/gene/cell-based therapies. While small molecules remain the largest fraction, their percentage has been declining substantially over the past 5 years. Taking together, these findings testify to the commitment of the pharmaceutical industry for innovative treatments, including conditions for which no approved therapies existed. On the other hand, there also is a trend for approvals for narrowly focused conditions such as tumors defined by genetic alterations.

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Naunyn-Schmiedeberg's archives of pharmacology, 398, Springer, Berlin, Heidelberg, 2025, https://doi.org/10.1007/s00210-025-04020-2

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