FDA original new drug approvals in the first quarter of 2025

Year 2025, Volume: 4 Issue: 2, 94 - 105, 31.08.2025

Senem Ertan-ahmed Yılmaz Çapan Adem Şahin

Abstract

Drug development efforts continue to increase, driven by the ongoing pursuit of innovative, more effective and safer treatments. This article aims to review and analyse new drug applications (NDAs) approved by the United States Food and Drug Administration (FDA) during Q1 of 2025 to provide insight into newly approved drugs and emerging trends in drug development. The evaluation revealed the approval of a total of six new molecular entities (NME) (24%), one new active ingredient (4%), seven new dosage forms (28%), two new combinations (8%), eight new formulations/ new manufacturers (32%), and one medical gas (4%). Approved NMEs are suzetrigine (JournavxTM), a NaV1.8 voltage-gated sodium channel inhibitor that is indicated for pain; gepotidacin (Blujepa™), an antibacterial drug aimed at inhibiting bacterial DNA gyrase and topoisomerase IV for uncomplicated urinary tract infections; fitusiran (Qfitlia™), a double-stranded siRNA designed to specifically inhibit synthesis of antithrombin for hemophilia; an alkylating agent treosulfan (GrafapexTM); a MEK inhibitor mirdametinib (GomekliTM); and CSF1R inhibitor vimseltinib (Romvimza™) targeting cancer/tumors. In conclusion, these works highlight the latest progress and emerging strategies of drug development studies and indicate that drug companies are increasingly shifting their R&D activities to develop innovative treatments with better efficacy & safety profile, transformative medicines with new mod of action to address the unmet need. Despite the uncertainties and confusion as a result of the FDA administrative changes, the wish is to continue to see a rise in the number of drug approvals for the remainder of the year 2025.

Keywords

FDA , first quarter , new dosage forms , new drug approvals , new molecular entities

Ethical Statement

Not applicable, because this article does not contain any studies with human or animal subjects.

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