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February 18, 2014
07:36 EDTNAVBNavidea announces priority review for sNDA to expand Lymphoseek labeling
Navidea Biopharmaceuticals announced that the U.S. Food and Drug Administration has accepted the Supplemental New Drug Application and granted a Priority Review for the expanded use of Lymphoseek Injection indicated for sentinel lymph node detection in patients with head and neck cancer. Under the Prescription Drug User Fee Act, the FDA has set a target review date for the Lymphoseek sNDA of June 16. The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options. Lymphoseek is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
News For NAVB From The Last 14 Days
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July 30, 2015
07:34 EDTNAVBNavidea reiterates FY15 Lymphoseek product revenue view $10M-$12M
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07:34 EDTNAVBNavidea reports Q2 EPS (6c), two estimates (4c)
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July 29, 2015
07:32 EDTNAVBNavidea wins $1.7M fast track NIH SBIR grant for evaluation of RA treatment
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July 28, 2015
07:35 EDTNAVBNavidea, MGH to evaluate Manocept for detection of cardiovascular disease
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July 23, 2015
08:50 EDTNAVBNavidea announces peer-reviewed publication of data on Lymphoseek
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