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 targeting prostate-specific membrane antigen (PSMA), originally developed by the Heidelberg group of the Deutsches Krebsforschungszentrum (German Cancer Research … WebDec 20, 2024 · The FDA has approved the imaging product TLX591-CDx (Illuccix) as a radioactive diagnostic agent for PET of prostate-specific membrane antigen (PSMA) …
Prostate Cancer Trial in St Leonards, Perth (177Lu-DOTA-TLX591 ...
WebMay 6, 2024 · This multinational, multicenter, prospective, randomized, controlled, open label Phase 3 study is designed to investigate and confirm the benefits and risks associated … WebTelix is pleased to share the company had a pre-NDA meeting with the United States Food and Drug Administration (FDA) on the 24th of July to discuss the Company’s plan for the submission of a New Drug Application … john wharton md baton rouge la
NDA Submitted for Prostate Cancer Companion Diagnostic, TLX591 …
WebMar 26, 2024 · TLX591 is a HuX591 monoclonal antibody conjugated with a DOTA chelator and labeled with the radioactive isotope 177Lu = therapeutic rfp 177Lu-DOTA-TLX591. As … WebOct 16, 2024 · The bridging study is required to provide data obtained in a Chinese population to establish that the diagnostic efficacy of TLX591-CDx is equivalent in … WebTelix notes that the sales of the TLX591-CDx kit during the quarter are not indicative of a reimbursed diagnostic imaging product volume or pricing. Page 3 Clinical Programs Update Telix continues to progress its clinical pipeline, with a core focus on prostate, kidney and brain cancer and rare diseases (bone marrow conditioning). ... how to harvard reference images