ARTICLE | Clinical News
Cimzia regulatory update
April 28, 2017 5:55 PM UTC
UCB said FDA issued a complete response letter in March to an sBLA for Cimzia certolizumab pegol to treat polyarticular juvenile idiopathic arthritis, citing concerns regarding the reliability of submitted pharmacokinetic data. The company said it is working with FDA and a third party bioanalytical laboratory to address the issue...
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