New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
January 15, 2013
08:04 EDTNAVBNavidea completes study of radiopharmaceutical NAV4694
Navidea Biopharmaceuticals announced the completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker for visual detection and quantification of cerebral b-amyloid in diagnosing Alzheimer's disease, or AD. The study was designed and conducted by Navidea's partner, AstraZeneca, to assess the effects of various mass amounts of AZD4694, or NAV4694, on safety and the efficacy of Positron Emission Tomography scanning in subjects with AD and in healthy volunteers. Evaluations were completed on the effects of two mass doses of the radioligand on binding parameters and overall image quality. These endpoints are typical and important requirements of drug registration dossiers filed with regulatory authorities for approval of diagnostic agents.
News For NAVB From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
October 15, 2014
09:20 EDTNAVBOn The Fly: Pre-market Movers
Subscribe for More Information
08:03 EDTNAVBNavidea names Gonzalez CEO
Subscribe for More Information
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.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use