Telix Pharmaceuticals Limited (ASX: TLX) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TLX101-CDx, also known as Pixclara (18F-floretyrosine or 18F-FET). This investigational PET agent is designed to differentiate between progressive or recurrent glioma (brain cancer) and treatment-related changes in both adult and pediatric patients.Pixclara has received Orphan Drug and Fast Track designations from the FDA, which support an expedited review process and provide closer collaboration with the agency.Though FET PET (Pixclara) is already recommended in international clinical practice guidelines for glioma imaging, there is presently no FDA-approved targeted amino acid PET agent available in the U.S. for imaging of brain cancer in adults and children.The material has been provided by InstaForex Company – www.instaforex.com
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