Radiopharm Aligns With FDA On Single Pivotal Phase 3 RAD101 Trial For Brain Metastases

Radiopharm Theranostics said it received the final minutes of its end-of-Phase 2 meeting with the FDA, confirming agreement on the design of a single pivotal Phase 3 trial for RAD101, its investigational imaging agent. The update establishes alignment on trial design but does not indicate FDA approval or provide additional trial details.