The FDA approved 46 novel drugs in 2025, with 70% receiving approval in the United States before any other country, according to a report from the Center for Drug Evaluation and Research (CDER). The 2025 tally falls short of the 50 novel drug approvals recorded in 2024.That slowdown has carried into the start of the new year. January 2026 saw just one novel drug approved, down from three approvals in January 2025.