Navidea, collaborators announce NAV4694 presentations Navidea Biopharmaceuticals announced that collaborators from the Department of Nuclear Medicine at University Hospital of Leipzig are planning presentations highlighting Navidea’s PET imaging agent, NAV4694, at the German Society of Nuclear Medicine Annual Congress in Hannover, Germany. NAV4694 is an investigational Fluorine-18 labeled beta-amyloid imaging agent currently being evaluated in late stage clinical trials for use as an aid in differential diagnosis and to monitor progression of Alzheimer's disease, Mild Cognitive Impairment and other forms of neurodegenerative dementia.
Navidea 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.