FDA Approved 46 Novel Drugs in 2025: Half for Rare Diseases
The FDA's drug centre CDER approved 46 novel drugs in 2025; 43% were first-in-class and 50% had orphan drug designation. It also approved 18 biosimilars in the same year.
The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, i.e. drugs never before approved or marketed in the U.S.: 34 new molecular entities and 12 biologics. The number was 50 in 2024 and 55 in 2023. According to CDER, the 2025 count is similar to the five-year average and above the historical average of 38 novel drugs per year since 2007; together with CBER, the biologics centre, there were 58 novel approvals in 2025.
The profile of the approvals stands out: 20 of the 46 drugs (43%) were first-in-class and 23 (50%) received orphan drug designation for rare diseases. 33 drugs (72%) used at least one expedited programme: fast track for 18 (39%), breakthrough therapy for 15 (33%), priority review for 21 (46%) and accelerated approval for 11 (24%). 39 drugs (85%) were approved on the first review cycle, and 32 (70%) were approved in the U.S. before any other country. Notable examples include the first-in-class non-opioid pain medicine Journavx (suzetrigine), the dry eye treatment Tryptyr (acoltremon) and Forzinity (elamipretide) for Barth syndrome.
On biosimilars, CDER approved 18 in 2025, 4 of them for reference products that previously had no approved biosimilar: the rapid-acting insulin biosimilars Merilog and Kirsty, Omlyclo for indications such as asthma and chronic hives, and Poherdy for certain breast cancers. Since 2015 CDER has approved 81 biosimilars for 20 reference products. The entry of these new medicines into the Turkish, Azerbaijani and Kazakh markets depends on each country's own registration process; at CSC we follow these developments closely.
Source: U.S. FDA, CDER report "Advancing Health Through Innovation: New Drug Therapy Approvals 2025" (January 2026) and the "Novel Drug Approvals for 2025" page (fda.gov).