Navidea Biopharmaceuticals Inc.
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Navidea Biopharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications.
October 16, 2014 
Navidea Biopharmaceuticals, Inc. has announced that that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the granting of marketing authorization for Lymphoseek 250 micrograms kit for radiopharmaceutical preparation in the European Union.
September 29, 2014 
June 17, 2014 — Navidea Biopharmaceuticals Inc. announced results from a post-hoc analysis of patient data from the company’s phase III clinical trial (NEO3-06) of Lymphoseek in head and neck cancer.
June 17, 2014 
June 13, 2014 — The U.S. Food and Drug Administration (FDA) today approved a new use for Navidea Biopharmaceuticals’ Lymphoseek (technetium Tc-99m tilmanocept) injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region.
June 13, 2014 Navidea Biopharmaceuticals Inc. held an update meeting with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the pending Marketing Authorization Application (MAA) of Lymphoseek (technetium Tc 99m tilmanocept) Injection.
April 16, 2014 
Navidea Biopharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review an additional Supplemental New Drug Application (sNDA) for the proposed expanded label for Lymphoseek (technetium 99m tilmanocept) Injection to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities.
March 07, 2014 
Navidea Biopharmaceuticals Inc. is a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals. It announced the U.S. Food and Drug Administration (FDA) has accepted the Supplemental New Drug Application (sNDA) and granted a Priority Review for the expanded use of Lymphoseek (technetium 99m tilmanocept) Injection indicated for sentinel lymph node (SLN) detection in patients with head and neck cancer. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a June 16 target review date for the Lymphoseek sNDA.
February 28, 2014 September 3, 2013 — Navidea Biopharmaceuticals Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced it has signed an agreement with Siemens’ PETNET Solutions that grants PETNET Solutions the right to manufacture Navidea’s fluorine-18 labeled NAV4694.
September 03, 2013 
Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, announced the U.S. launch of Lymphoseek (technetium Tc 99m tilmanocept) Injection for use in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. Lymphoseek was approved by the U.S. Food and Drug Administration (FDA) in March 2013.
May 08, 2013 Navidea Biopharmaceuticals Inc. announced the peer-reviewed publication of results from a clinical trial of NAV4694 in healthy subjects and those with diagnosed forms of dementia. The trial assessed the performance of Navidea’s Fluorine-18 labeled amyloid imaging candidate, NAV4694, in a head-to-head comparison with the acknowledged benchmark, gold-standard amyloid imaging agent, 11C-labeled Pittsburgh Compound-B (PiB). Results demonstrated that NAV4694 displayed imaging characteristics nearly identical to those of PiB and the authors believe these results show that NAV4694 may be useful in the early and differential diagnosis of Alzheimer’s disease (AD). The study, “Head-to-Head Comparison of 11C-PiB and 18F-AZD4694 (NAV4694) for ?-Amyloid Imaging in Aging and Dementia,” was published in the current online edition of the Journal of Nuclear Medicine and will appear in the June print edition.
April 29, 2013