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News Breaks
March 13, 2013
13:09 EDTNAVB, CAHFDA approves Navidea Lymphoseek injection for use in lymphatic mapping
Navidea Biopharmaceuticals (NAVB) announced U.S. Food and Drug Administration approval of Lymphoseek Injection, a novel product indicated for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek will be sold and distributed in the U.S. on an exclusive basis by Cardinal Health (CAH).
News For NAVB;CAH From The Last 14 Days
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October 16, 2014
16:20 EDTCAHMcKesson initiated with an Outperform at RBC Capital
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16:18 EDTCAHCardinal Health initiated with an Outperform at RBC Capital
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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.
October 13, 2014
07:37 EDTCAHAmerican Society of Anesthesiologists to hold annual meeting
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October 8, 2014
08:33 EDTCAHCardinal Health and Ohio State University complete $13M medical imaging facility
Cardinal Health , the Ohio State University and State of Ohio Third Frontier Commission have completed a five-year-long project to create a new, $13M molecular imaging pharmaceuticals center. The 27,000-square-foot facility will research and produce specialized pharmaceuticals called "imaging agents," which are injected into the body and seek out particular cellular functions that are indicative of specific disease processes. The new center supports more than 80 employees.
October 6, 2014
07:12 EDTCAHThe MedTech Conference holds a conference
AdvaMed 2014 is being held in Chicago on October 6-8.

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