Precision Medicine Drug Approvals in 2025: New Drugs and Expanded Indications
Precision Medicine Online tracks FDA approvals for the following types of drugs: therapies approved for biomarker-defined populations; n-of-1 treatments; CAR T and other types of cell-based therapies; and nucleic acid medicines. This list contains FDA approvals of new molecular entities and expanded or amended indications of already marketed drugs based on FDA databases and company documents. Drugs that the FDA has converted to regular approval for the exact indication it previously granted accelerated approval are not on this list. However, if in converting an accelerated approval to a regular approval, the FDA amends or expands the indication for the treatment, we list those.