A year in pharmacology: new drugs approved by the US food and drug administration in 2025

The US Food and Drug Administration approved 45 new drugs and 4 new cellular and gene therapy products in 2025, that is, a total of 49 new medical therapies. Oncology, hematology/immunotherapy, and cardiovascular/respiratory drugs remain most frequent. Among oncology drugs, there is a trend for targeting ever smaller subtypes of malignancies and/or rarer malignancies. Trends over the past 6 years include steady levels of first-in-indication (about 10%), first-in-class (about 38%), and next-in-class (about 51%) approvals. Along with a large share of approvals in orphan indications (> 50%), fast track approval pathways are now regularly representing more than half of all new approvals. While small molecules remain the bedrock of novel medical treatments (about 60%), there is a growing segment of mRNA, gene, and cell-based pharmacological approaches. These data testify to the innovative strength of academia, biotechnology, and established pharmaceutical companies in providing innovative treatments, often related to previously unmet medical needs.