Pfizer's Xeljanz Gains FDA Panel Nod In Psoriatic Arthritis, But Labeling Questions Remain
US advisory committee recommends approval of new indication for the JAK inhibitor but does not want any radiographic progression data in labeling amid questions about effect.
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FDA says during meeting on Xeljanz application that it is interested in feedback on creating a control group for non-inferiority trials.
Arthritis Advisory Committee members say the company should bear some of the responsibility for managing the risk of shingles with the JAK inhibitor.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.