The U.S. Food and Drug Administration (FDA) reported that it approved 45 novel drugs year-to-date through September 28, 2026. The total exceeds the 31 new drugs approved over the same period last year and the 34 approved over the same period in 2024. The FDA approved a record 59 novel drugs during the 2018 calendar year. For comparative purposes, the FDA approved a total of 46 novel drugs in 2025.