Telix Pharmaceuticals Ltd. (AU:TLX) has released an update.
Telix Pharmaceuticals has submitted a New Drug Application for Pixclara®, an imaging agent designed to enhance the diagnosis and management of glioma, a common and aggressive brain cancer. Pixclara® promises to provide precision imaging crucial for patient treatment decisions, with the FDA granting it Orphan Drug and Fast Track designations to expedite its review. This submission marks a significant step towards addressing the need for targeted amino acid PET agents in the U.S. market, with potential FDA approval advancing Telix’s presence in neuro-oncology imaging.
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