Immunomedics CEA-Scan gains unanimous approval recommendation at Feb. 16 panel meeting.
This article was originally published in The Gray Sheet
Executive Summary
IMMUNOMEDICS CEA-SCAN IDENTIFIES LESIONS MISSED BY CT, FDA's Patricia Keegan, MD, branch chief in the Division of Oncology at the Center for Biologics Evaluation and Research, told a Feb. 16 meeting of FDA's Medical Imaging Drugs Advisory Committee. The committee recommended approval of the murine monoclonal antibody fragment-based imaging agent directed against the carcinoembryonic antigen (PLA 91-0209).