28 April 2028 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA for its new drug application for TLX101-CDx (floretyrosine F18 or 18F-FET, Pixclara), an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer.

The FDA stated additional confirmatory clinical evidence is required to progress the application, despite a robust consultation process prior to submission and during review of the new drug application.

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