The US Food and Drug Administration’s Oncology Center of Excellence released a trio of draft guidances on 18 August aimed at streamlining cancer-drug development. The first document, Docket FDA-2025-D-1757, outlines a data-driven approach to determining dosage and scheduling for therapeutic radiopharmaceuticals, moving away from limits historically based on external-beam radiation therapy. A second draft guidance focuses on how sponsors should prespecify and analyse overall survival as a safety end-point in oncology trials, underscoring the agency’s increasing emphasis on clinically meaningful outcomes. Separately, the FDA issued recommendations that give developers greater latitude in designing trials that test combination cancer therapies without relying solely on traditional factorial designs. Collectively, the documents signal the regulator’s intent to offer more flexible, scientifically grounded pathways for sponsors while maintaining patient safety. Stakeholders can submit comments before the agency finalises the guidances.