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

Abstract

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.