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GlobeNewsWire
14 days ago
FDA Accepts NDA for TLX101-Px (Pixclara®)
MELBOURNE, 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 Company's 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.