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UCB To Provide More Cimzia Information Following FDA "Complete Response"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

UCB will have to submit "additional information" and clarifications to FDA following receipt of a "complete response" letter from the agency for its PEGylated Fab fragment TNF inhibitor Cimzia (certolizumab pegol) for treatment of Crohn's disease, the company said Dec. 22

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