FDA accepts Telix brain cancer imaging drug application
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FDA Accepts NDA for TLX101-Px (Pixclara®)
April 9, 2026 6:51 PM EDTMELBOURNE, Australia and INDIANAPOLIS, April 10, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Companys resubmitted New Drug Application (NDA) for TLX101-Px1, (Pixclara®2, Floretyrosine F 18 or 18F-FET), an investigational PET3 agent for the imaging of glioma (brain cancer), and has assigned a PDUFA4 goal date of September 11, 2026.
The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric... More
