10 April 2026 - Telix today announces that the US FDA has accepted the Company’s resubmitted new drug application for TLX101-Px, (Pixclara, floretyrosine F 18 or 18F-FET), an investigational PET agent for the imaging of glioma and has assigned a PDUFA goal date of 11 September 2026.

The approval of TLX101-Px will fulfil a significant unmet medical need for the characterisation of recurrent or progressive glioma from treatment related changes in both adult and paediatric patients.

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