7 December 2020 -  Telix announces today that the Company’s preliminary application to the TGA for TLX591-CDx was made at the same time as Telix’s new drug application to the United States FDA, the first successful commercial new drug application for PSMA imaging in the United States. 

This represented a major commercial milestone for the Company and followed Telix’s European submission in April 2020. 

In addition, a Medical Services Advisory Committee (MSAC) application is already in progress and Telix expects that MSAC approval and commercial availability of TLX591-CDx should coincide around May-June of 2021, subject to TGA review and approval.

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