Today, the FDA Center for Drug Evaluation and Research (CDER) released its 15th annual New Drug Therapy Approvals report, outlining major milestones in drug development and regulatory review achieved throughout 2025. The report provides a comprehensive overview of novel drug approvals, biosimilar progress, and regulatory activity, reflecting sustained innovation across therapeutic areas and continued regulatory engagement throughout the drug development lifecycle.
Overview of 2025 Drug Approvals
In 2025, CDER approved 46 novel drugs, defined as drugs never before approved or marketed in the United States. These approvals included 34 new molecular entities and 12 biologics, underscoring a diverse and evolving development pipeline. Notably, 70% of these novel therapies were approved in the United States before any other country, highlighting the continued role of the U.S. regulatory system in facilitating early patient access to innovative treatments.
In collaboration with the FDA’s Center for Biologics Evaluation and Research, the total number of novel drug approvals reached 58 in 2025, reflecting coordinated regulatory efforts across FDA centers.
Focus on Rare Diseases and Unmet Medical Needs
A substantial proportion of newly approved therapies addressed rare and serious conditions. Twenty-three novel drugs received Orphan Drug Designation, supporting the treatment, diagnosis, or prevention of rare diseases. These approvals span oncology, genetic disorders, immunologic diseases, and other areas where limited treatment options previously existed.
Progress in Biosimilar Development
In addition to novel drug approvals, CDER approved 18 biosimilars in 2025, including four biosimilars for three reference products that previously had no approved biosimilar alternatives. These decisions are expected to enhance market competition and potentially improve patient access to biologic therapies.
Regulatory Oversight and Review Activity
Beyond approvals, the report highlights CDER’s continued emphasis on regulatory rigor and patient safety. During 2025, the Center issued 19 complete response letters for 18 novel drugs, reflecting ongoing assessment of benefit–risk profiles and the need for additional data or clarification prior to approval.
CDER also reported extensive engagement across the development continuum, reviewing more than 3,000 Investigational New Drug applications and approximately 12,300 clinical trial protocols, representing an increase of 600 protocols compared with 2024. This activity illustrates sustained collaboration between regulators and drug developers from early-phase research through late-stage clinical evaluation.
What Are “Novel” Drugs?
Within the context of the CDER report, “novel” drugs refer to new drugs never before approved or marketed in the United States. These products represent original approvals rather than new indications, reformulations, or expanded uses of previously approved therapies. Information on all FDA-approved drugs and biological products is publicly available through Drugs@FDA.
Scope of 2025 Novel Drug Approvals
The 2025 approvals encompassed a wide range of therapeutic areas, including oncology, cardiovascular disease, infectious diseases, rare genetic disorders, immunology, neurology, and respiratory medicine. CDER also continued to approve previously authorized drugs for new indications and broader patient populations, further extending the clinical impact of existing therapies.
The full list of 46 novel drug approvals for 2025, including approval dates, active ingredients, and FDA-approved uses, is detailed in the official CDER report.
Written by Nare Hovhannisyan, MD