New drugs approved by the FDA in 2025: Synthesis and clinical applications.

In 2025, the Center for Drug Evaluation and Research (CDER) approved 46 new drugs, comprising 34 new molecular entities (NMEs) and 12 new biologicals. Small molecules dominated (31 drugs, 67.4%), with kinase inhibitors (10 drugs) remaining prominent and expanding beyond oncology. Therapeutic areas were led by oncology (35%), cardiovascular (11%), and allergy/inflammatory diseases (9%). The approvals sustained the recent approval rate and showed diverse modalities including proteins and oligonucleotides. This review systematically summarizes the 31 approved small molecules, focusing on their target mechanisms, clinical indications, and synthesis processes. Furthermore, the non-small-molecule therapeutics are evaluated regarding their target mechanisms, and clinical impacts. It aims to inspire the development of efficient synthetic methods and provide practical references for future drug design targeting complex and rare diseases.