FDA accepts Telix NDA for new prostate cancer imaging agent

Telix Pharmaceuticals

23 July 2024 - Telix today announces that the US FDA has accepted the filing of its new drug application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer. 

The PDUFA goal date is 24 March 2025.

Read Telix Pharmaceuticals press release

Michael Wonder

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Michael Wonder