Posted by Michael Wonder on 23 Oct 2024
FDA accepts new drug application and grants priority review for TLX101-CDx (Pixclara) brain cancer imaging agent
24 October 2024 - Telix Pharmaceuticals today announces that the US FDA has accepted the new drug application for TLX101-CDx (Pixclara), an agent for the imaging of glioma.
The application has been granted priority review and designated a PDUFA goal date of 26 April 2025, paving the way for a US commercial launch in 2025.
