Telix Pharmaceuticals Ltd. (AU:TLX) has released an update.
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Telix Pharmaceuticals Ltd. has announced that the FDA has accepted its New Drug Application for TLX101-CDx, a brain cancer imaging agent, and granted it priority review. This development could significantly enhance the precision of glioma diagnosis and management in the U.S., addressing a critical unmet need in brain cancer imaging. Telix anticipates a commercial launch in 2025, pending regulatory approval, potentially revolutionizing the standard of care in the U.S. market.
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