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Source documentNasdaq· April 10, 2026
Novel Drugs Approved By The FDA In 2025
View original at nasdaq.comNovel Drugs Approved By The FDA In 2025 (RTTNews) - The U.S. Food and Drug Administration (FDA) in 2025 approved 46 novel drugs, including 34 new molecular entities (NMEs) and 12 biologics…
Data points we hold from this source
| U.S. Food and Drug Administration · accelerated approvals | 11 drugs |
| U.S. Food and Drug Administration · biologics approved | 12 biologics |
| U.S. Food and Drug Administration · fast track designations | 18 drugs |
| U.S. Food and Drug Administration · first in class drugs | 20 drugs |
| U.S. Food and Drug Administration · new molecular entities approved | 34 NMEs |
| U.S. Food and Drug Administration · novel drugs approved | 46 drugs |
| U.S. Food and Drug Administration · priority reviews | 21 drugs |
| U.S. Food and Drug Administration · rare disease drugs | 23 drugs |