Telix submits NDA for prostate cancer imaging agent TLX007-CDx to the US FDA, aiming to extend PSMA-PET imaging distribution.

Telix Pharmaceuticals submits NDA for new prostate cancer imaging agent, TLX007-CDx, to the US FDA. The proprietary cold kit aims to extend distribution profile of PSMA-PET imaging compared to gallium-68 PSMA-PET agents. The innovative kit's design allows for more flexible production using 68Ga from newer high activity generators and cyclotrons. Regulatory approval could expand availability and distribution of PSMA-PET imaging.

May 27, 2024
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