Date: August 10, 2026 PMID: 42573944 Category: N/A Authors: Kai Chen, Yixuan Zhao, Kentaro Takeda, Ying Yuan Abstract: The US Food and Drug Administration (FDA) launched Project Optimus and issued guidance to reform dose-finding and selection trials, shifting the paradigm from identifying the maximum tolerated dose (MTD) to determining the optimal biological dose (OBD), which optimizes the risk and benefit of treatments. The FDA's guidance emphasizes the importance of co