美国FDA药物评价和研究中心（CDER）：2025年度新药获批报告（英文版）

CDER approved many drug therapies in 2025. These approvals, spanning a wide array of diseases and conditions, aim to help people live better and potentially longer lives. Innovation Across Medical Conditions In 2025, we approved 46 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also approved previously approved drugs for new conditions, patient populations, or in new doses or formulations. The 2025 actions, both novel and other important drug approvals, fo