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Stock Market & Financial Investment News

News Breaks
March 13, 2013
15:45 EDTNAVB, NAVBNavidea to host conference call
Conference call to discuss FDA approval of Lymphoseek Injection will be held on March 13 at 4 pm.
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October 15, 2014
09:20 EDTNAVBOn The Fly: Pre-market Movers
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08:03 EDTNAVBNavidea names Gonzalez CEO
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08:01 EDTNAVBNavidea names Gonzalez CEO
07:03 EDTNAVBNavidea announces FDA sNDA approval for Lymphoseek extended use
Navidea Biopharmaceuticals announced that the U.S. Food and Drug Administration has approved the Supplemental New Drug Application for the expanded use of Lymphoseek injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications. The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging to enable pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures. Lymphoseek will be immediately available using existing reimbursement codes for this expanded population of cancer patients. In the approval action letter, the FDA also outlined a post-marketing requirement for initiation of a pediatric study in solid tumor cancer with a target date for submission in 2018.

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