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Source documentNasdaq· April 10, 2026

Novel Drugs Approved By The FDA In 2025

View original at nasdaq.com

Novel 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…

Opening lines of the source · Nasdaq · short snapshot — read the full document at the original

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