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Navidea submits Lymphoseek MAA to EMA

Navidea Biopharmaceuticals has submitted a Marketing Authorization Application for its investigational radiopharmaceutical Lymphoseek injection, a novel intraoperative lymphatic mapping agent, to the European Medicines Agency. Navidea is seeking marketing approval for Lymphoseek in the EU for use in ILM, a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. The Lymphoseek MAA has proposed the use of the agent in general lymphatic mapping not restricted to any particular solid tumor type.