Navidea Biopharmaceuticals has received notification from the FDA that the Prescription Drug User Fee Act (PDUFA) date for 99m-Tc-Tilmanocept (Lymphoseek) has been pushed back to Sept. 10, a 90-day extension from the initial PDUFA date of June 10. Lymphoseek is an investigational radioactive tracing agent for lymphatic mapping and lymphoscintigraphy.
Adaptive radiotherapy (ART) for head and neck cancer treatment may solve some of the problems inherent to intensity-modulated radiotherapy (IMRT) and benefit patient with less technical difficulty than previously believed, according to preliminary findings released online Feb. 9 in the International Journal of Radiation Oncology Biology Physics.
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FDG PET could be used as a noninvasive surrogate marker for tumor growth and viability in treatment of head and neck cancer, based on a rodent model study published in the December issue of
Radiology.
The Molecular Imaging Biomarker Research Group of Siemens Medical Solutions USA has completed a Phase II multicenter clinical trial of its HX4 positron PET imaging biomarker, which is designed to detect hypoxia—a reduction in tissue oxygen levels—in solid tumors.
Infinitt North America, a developer of image and information management technologies for healthcare, has received FDA clearance for its fusion software, Xelis Fusion. The software is now available to the North American market.