Navidea: FDA grants lymphseek injection fast track qualification
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Last Update: 2013-12-11
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Source: Internet
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Author: User
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Source: navidea biopharmaceutical company of China Council for the promotion of drugs on December 10, 2013 said that the US Food and Drug Administration (FDA) approved lymphseek injection for sentinel lymph node detection in patients with head and neck cancer as a fast track qualification The company plans to submit a supplementary new drug application for lymphseek by the end of the year The FDA approved lymphseek in March 2013 to map the lymph nodes of breast cancer and melanoma patients to help diagnose and evaluate the possibility of cancer spread William Regan, senior vice president, global regulatory strategy, navidea, said: "after submitting the supplementary application, we look forward to working closely with the FDA to bring the extended use of lymphseek to the market as soon as possible, and it will be the first reagent for sentinel lymph node detection." Lymphseek injection is a new, receptor targeted, small-molecule diagnostic agent for the lymph mapping of breast cancer and melanoma patients, in order to help diagnose and evaluate the possibility of cancer spread It is a kind of local lymph mapping reagent assisted by a hand-held γ counter to drain lymph nodes from the primary tumor site of breast cancer or melanoma patients Original link: http://www.rttnews.com/2237015/fda-grants-fast-track-design-to-navidea-biopharma-s-limphoseek-injection.aspx
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