FDA original new drug approvals in the first quarter of 2025

Senem Ertan-ahmed; Yılmaz Çapan; Adem Şahin

doi:/ejls.1747184

FDA original new drug approvals in the first quarter of 2025

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

Ethical Statement

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

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Details

Primary Language

English

Subjects

Pharmaceutical Delivery Technologies, Pharmacology and Pharmaceutical Sciences (Other)

Journal Section

Review Article

Authors

Senem Ertan-ahmed This is me
0009-0009-1846-8449
United Kingdom

Yılmaz Çapan This is me
0000-0003-1234-9018
Türkiye

Adem Şahin ^*
0000-0002-3996-2931
Türkiye

Publication Date

August 31, 2025

Submission Date

July 21, 2025

Acceptance Date

August 11, 2025

Published in Issue

Year 2025 Volume: 4 Number: 2

DOI

https://doi.org//ejls.1747184

IZ

https://izlik.org/JA48LS34XY

Cite

RIS / Bibtex

APA

Ertan-ahmed, S., Çapan, Y., & Şahin, A. (2025). FDA original new drug approvals in the first quarter of 2025. European Journal of Life Sciences, 4(2), 94-105. https://doi.org//ejls.1747184

AMA

1.Ertan-ahmed S, Çapan Y, Şahin A. FDA original new drug approvals in the first quarter of 2025. Eur J Life Sci. 2025;4(2):94-105. doi:/ejls.1747184

Chicago

Ertan-ahmed, Senem, Yılmaz Çapan, and Adem Şahin. 2025. “FDA Original New Drug Approvals in the First Quarter of 2025”. European Journal of Life Sciences 4 (2): 94-105. https://doi.org//ejls.1747184.

EndNote

Ertan-ahmed S, Çapan Y, Şahin A (August 1, 2025) FDA original new drug approvals in the first quarter of 2025. European Journal of Life Sciences 4 2 94–105.

IEEE

[1]S. Ertan-ahmed, Y. Çapan, and A. Şahin, “FDA original new drug approvals in the first quarter of 2025”, Eur J Life Sci, vol. 4, no. 2, pp. 94–105, Aug. 2025, doi: /ejls.1747184.

ISNAD

Ertan-ahmed, Senem - Çapan, Yılmaz - Şahin, Adem. “FDA Original New Drug Approvals in the First Quarter of 2025”. European Journal of Life Sciences 4/2 (August 1, 2025): 94-105. https://doi.org//ejls.1747184.

JAMA

1.Ertan-ahmed S, Çapan Y, Şahin A. FDA original new drug approvals in the first quarter of 2025. Eur J Life Sci. 2025;4:94–105.

MLA

Ertan-ahmed, Senem, et al. “FDA Original New Drug Approvals in the First Quarter of 2025”. European Journal of Life Sciences, vol. 4, no. 2, Aug. 2025, pp. 94-105, doi:/ejls.1747184.

Vancouver

1.Senem Ertan-ahmed, Yılmaz Çapan, Adem Şahin. FDA original new drug approvals in the first quarter of 2025. Eur J Life Sci. 2025 Aug. 1;4(2):94-105. doi:/ejls.1747184