Navidea granted FDA Fast Track Designation for Lymphoseek Injection Navidea Biopharmaceuticals announced that the US Food and Drug Administration has granted Fast Track designation to Lymphoseek Injection for sentinel lymph node detection in patients with head and neck cancer. Navidea intends to file the supplemental New Drug Application for Lymphoseek before year-end. Lymphoseek was approved by the FDA in March for use in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. William J Regan, Navidea Senior Vice President for Global Regulatory Strategy, says “After filing the sNDA, we look forward to working closely with the FDA to bring to market as quickly as possible an expanded label for Lymphoseek and what will be the first agent indicated in sentinel lymph node detection."
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