Posted by Michael Wonder on 16 Apr 2024
TLX101-CDx (Pixclara) granted FDA fast track designation
16 April 2024 - Telix Pharmaceuticals today announces that the US FDA has granted fast track designation for the Company's investigational glioma imaging product, TLX101-CDx (Pixclara, 18F-floretyrosine or 18F-FET).
Amino acid PET is currently included in US and European guidelines for the imaging of gliomas, however there is no FDA approved targeted PET agent for brain cancer imaging in the US.
