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News Breaks
June 16, 2014
16:00 EDTNAVBNavidea reduces R&D expense to less than $20M for 2014
In a regulatory filing, Navidea Biopharmaceuticals disclosed that on June 16, in a conference call, Dr. Michael Goldberg, Interim CEO of Navidea Biopharmaceuticals, stated that, as a result of the previously announced reorganization plan to reduce the company’s cash burn, the company’s previous 2014 research and development expense guidance of between $25M to $30M is being reduced to less than $20M for the calendar year.
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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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