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In Brief: Immunomedics

This article was originally published in The Gray Sheet

Executive Summary

Immunomedics: Firm's CEA-Scan colorectal diagnostic imaging agent shows 60% accuracy in predicting tumor resectability in patients with known or suspected recurrent colorectal cancer, compared to 47% for computed tomography alone, according to data presented May 23 at a meeting of the American Society of Clinical Oncologists in Los Angeles. The results are part of a Phase III, 208-patient study conducted in response to FDA's May 1994 request for data to supplement the company's product license application submitted in 1991 ("The Gray Sheet" March 27, p. 39). The study results were submitted to FDA in March...

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Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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