Original drug products approved by the Food and Drug Administration (Center for Drug Evaluation and Research) in 2025

The annual review of new drugs approved by the FDA is an important tool for analyzing current trends in pharmacology and medicine, reflecting progress in the treatment of complex diseases, including oncological pathologies, orphan diseases, and infectious processes. The article aims to inform medical specialists and pharmacologists about current trends in the development and registration of innovative medicinal products in 2025.
The aim. To summarize and systematize data on the latest medicinal products launched in 2025, and to analyze their mechanisms of action.

Materials and methods. The presented data are taken from open sources and supplemented by the results of individual studies aimed to the investigate new mechanisms and approaches in therapy. The main list of new medicines and introductory information about them are taken from the report of the Food and Drug Administration (FDA) — "Novel Drug Approvals for 2025.

Results. In 2025, the FDA approved 46 drugs, of which 31 were small molecules and 15 were macromolecules. Among the drugs in the first group, 11 (24 % of all new drugs and 35 % of all new small molecules) are used in oncology, 2 are immunotropic, and 2 are for cardiology. The majority (16 drugs) belong to miscellaneous drug groups. Among biologicals, the largest portion consisted of monoclonal antibodies for the treatment of non-oncological diseases — 6 (13 % of all and 40 % of biologicals) and monoclonal antibodies for the treatment of oncological diseases — 5 (11 % of all and 33 % of biologicals). Nucleic acid-based drugs and protein molecules, excluding antibodies, accounted for 3 (7 % of all and 20 % of biologicals) and 1 (2 % of all and 7 % of biologicals) respectively.

Conclusion. The significant proportion of biopharmaceuticals among newly registered drug products in 2025 highlights the dynamic development of the pharmaceutical industry and its focus on personalized medicine and biotechnology. Therapy based on mAbs interacting with receptors, as well as immunotherapy based on newly discovered mechanisms of anti-tumor immunity, occupies a substantial part of the structure of original drugs. The search for new rational antibiotic combinations remains relevant. Small molecules still constitute the largest share of the original drug market, among which drug substances — ligands of new targets and oligonucleotide sequences are emerging. This review is compiled for medical specialists and pharmacologists to familiarize them with current trends in the registration of original drugs and in the therapy of malignant neoplasms, as well as orphan diseases.

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