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Telix Resubmits FDA Application for Brain Cancer Imaging Agent Pixclara®
8:34am on Monday 16th of March, 2026 AEDT
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Healthcare
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Telix Resubmits FDA Application for Brain Cancer Imaging Agent Pixclara®
8:34am on Monday 16th of March, 2026 AEDT
Key Points
Resubmission of NDA for TLX101-Px (Pixclara®) to U.S. FDA
Additional data and statistical analysis provided to address FDA concerns
TLX101-Px holds Orphan Drug and Fast Track designations
Targets unmet need in imaging recurrent or progressive gliomas
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Telix Pharmaceuticals (ASX:TLX)
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