Posted by Michael Wonder on 28 Aug 2025
Telix provides regulatory update on TLX250-CDx
28 August 2025 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA for the biologics license application for TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), an investigational PET2 agent for the diagnosis and characterisation of renal masses as clear cell renal cell carcinoma.
The complete response letter identifies deficiencies relating to the Chemistry, Manufacturing, and Controls package.
