WebJun 30, 2024 · The TLX591-CDx program is the Group’s most advanced program, with the product currently used under investigational (IND), clinical trial and special access use in the United States and Europe. TLX591-CDx – prostate cancer imaging In February 2024, Telix received positive guidance from the US Food and Drug Administration (FDA) regarding its WebMay 10, 2024 · The international, multi-centre randomised controlled Phase III trial will have around 390 subjects selected with the help of 68Ga-PSMA imaging with TLX591- companion diagnostics (CDx), Illuccix. A lead investigational product of Telix, Illuccix is intended for prostate cancer imaging. It is currently under the TGA’s priority evaluation.

Australian TGA Approves Illuccix® for Prostate Cancer Imaging

WebSep 24, 2024 · MELBOURNE, Australia and INDIANAPOLIS, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, 'Telix', the 'Company') today announces it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for TLX591-CDx (Kit for the preparation of 68 Ga-PSMA-11), a … WebSep 24, 2024 · About TLX591-CDx . TLX591-CDx (Kit for the preparation of 68 Ga-PSMA-11) is a proprietary formulation of PSMA-HBED-CC (PSMA-11), a novel imaging agent targeting prostate-specific membrane antigen (PSMA), originally developed by the Heidelberg group of the Deutsches Krebsforschungszentrum (German Cancer Research Centre, DKFZ). 2 The … therapeutic tape brands

Telix New Drug Application for Prostate Cancer …

WebDec 20, 2024 · TLX591-Dx is described as a kit for the preparation of Gallium-68 gozetotide (PSMA-11) injection. The imaging product was investigated in 2 prospective, open-label trials: PSMA-PreRP... WebMay 1, 2024 · TLX591-CDx (kit for the preparation of 68 Ga-PSMA-11 injection) is a proprietary formulation of PSMA-HBED-CC (PSMA-11), a novel small molecule agent … WebArduino - Home therapeutic talk therapy