Structure and function of therapeutic antibodies approved by the US FDA in 2025

In 2025, the 50th anniversary of the invention of hybridoma technology, the United States Food and Drug Administration (US FDA) approved a total of 44 new molecular entities (NMEs), of which 10 were therapeutic antibody-based molecules. Additionally, the US FDA approved 31 small molecules (of which one was a peptide), and 3 new nonantibody therapeutic proteins, but no new chimeric antigen receptor (CAR)-T-cell therapeutics. Of the new antibody-based biologics, two were antibody-drug conjugates, one was a T-cell engager-bispecific antibody, two were Fc-modified, half-life extended antibodies, and two targeted the complex coagulation pathway. The eighth novel anti-PD-1 antibody was also approved, along with the newest entry of biologics targeting the neonatal Fc receptor (FcRn). Additionally, two new entries in which hyaluronidase was coformulated with an antibody to provide rapid subcutaneous dosing were FDA-approved. Finally, the first antibody-like scaffold-fusion protein was approved that will compete in an antibody-rich environment.