Telix Reports First US Patients Dosed with FDA-Approved Pixclara for Glioma Imaging

Shots: Telix Pharmaceuticals reported that the first pts. in the US have been dosed with Pixclara (floretyrosine F-18), marking the start of commercial availability of the FDA-approved PET imaging drug for glioma Pixclara (IV) is indicated for use with PET to differentiate recurrent or progressive glioma from treatment-related changes in adults and pediatric patients one…

ByPrince GiriOctober 6, 2026

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Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging

Shots: The US FDA has accepted the resubmitted NDA for TLX101-Px (Pixclara; 18F-FET), an investigational PET imaging agent for the detection and characterization of glioma in adult and pediatric patients The US FDA has assigned a PDUFA date of 11’Sep, 2026; TLX101-Px has received Orphan Drug and Fast Track designations, addressing unmet needs in distinguishing…

ByPrince GiriApril 10, 2026

Telix Reports First US Patients Dosed with FDA-Approved Pixclara for Glioma Imaging

Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging

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