The FDA approved Telix Pharmaceuticals’ Pixclara (floretyrosine F-18, 18F-FET), making it the first FDA-approved FET-PET imaging agent for glioma. Telix said the approval is also the first U.S. PET imaging radiopharmaceutical specifically targeting brain cancer with the FET tracer. The agent is intended to help differentiate recurrent or progressive glioma from treatment-related changes, including in adults and pediatric patients at least 1 month old. The decision follows an earlier complete response letter that requested additional clinical evidence. For neuro-oncology, the approval strengthens imaging tools that reduce uncertainty in post-therapy assessment, a common challenge that impacts downstream treatment decisions and trial endpoints.