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CEA-Scan gets approvable letter from FDA
It's been a long road back for monoclonal antibody developer Immunomedicsand its CEA-Scan imaging agent, but the end is finally in sight.The Morris Plains, NJ, company reported this month that the Foodand Drug Administration has issued an approvable
It's been a long road back for monoclonal antibody developer Immunomedicsand its CEA-Scan imaging agent, but the end is finally in sight.The Morris Plains, NJ, company reported this month that the Foodand Drug Administration has issued an approvable letter for theagent.
CEA-Scan's path through the FDA's regulatory maze was entangledin 1994 when the agency issued a non-approvable letter for thecolorectal cancer imaging agent. Immunomedics worked with theagency to bring CEA-Scan's product license application (PLA) intoa form that FDA reviewers could accept, and an FDA panel recommendedapproval of the product in February (SCAN 2/28/96).
Final marketing approval for CEA-Scan is now subject mainlyto product labeling, Immunomedics said. Immunomedics has assignedU.S. marketing rights for the agent to Mallinckrodt Medical (SCAN4/10/96).
Assessing MACE Risk in Women: Can an Emerging Model with SPECT MPI Imaging Have an Impact?
December 9th 2024In research involving over 2,200 women who had SPECT MPI exams, researchers found that those who had a high score with the COronary Risk Score in WOmen (CORSWO) model had a greater than fourfold higher risk of major adverse coronary events (MACE).
