2025 FDA approvals: Formulation Outlook
In 2025, the US FDA has approved 46 novel drugs that year. Amongst those, 12 biologics—accounting roughly 25% of total approvals—include antibody-drug conjugates (ADCs), fusion proteins, and both mono- and bispecific monoclonal antibodies. While oncology remained the primary focus for the approved biologics, recent approvals also span a diverse range of therapeutic areas, including pulmonary, cardiovascular, renal, immunology, and neurology.





