Posted by Michael Wonder on 28 May 2024
Telix submits NDA for new prostate cancer imaging agent
27 May 2024 - Telix Pharmaceuticals today announces it has submitted a new drug application to the US FDA for TLX007-CDx, a new and proprietary cold kit ("Kit") for the preparation of PSMA-PET imaging for prostate cancer.
Subject to regulatory approval, this Kit will enable use of a PSMA imaging product with a considerably extended distribution profile compared to currently approved gallium 68 (68 Ga) PSMA-PET imaging agents.
