Recent regulatory and clinical developments include the FDA advisory committee voting against approval of Otsuka’s Rexulti-Zoloft combo for PTSD due to insufficient Phase 3 data, and the FDA issuing a complete response letter rejecting Roche’s proposed label expansion for Columvi. June 2025 also saw approvals such as Gilead’s twice-yearly HIV prevention shot and Nuvation Bio's ROS1 inhibitor for lung cancer. Additionally, plans for Phase 3 trials by Novo Nordisk and investigational immunomodulatory therapies were reported, indicating evolving therapeutic landscapes.