The FDA’s Center for Drug Evaluation and Research (CDER) has released its 15th annual New Drug Therapy Approvals report, offering a useful snapshot of the pace and direction of drug development in 2025.
In 2025, CDER approved 46 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also made other important approval decisions, such as approving previously approved drugs for new uses and broader patient populations. CDER’s novel drug approvals for 2025 are listed below.
For more information, download the report.