FDA Approves Tocilizumab for Treatment of Rheumatoid Arthritis

On January 8, 2010, the U.S. Food and Drug Administration approved tocilizumab (to be marketed under the trade name of Actemra) for the treatment of patients with moderate to severe rheumatoid arthritis who have had inadequate clinical responses to treatment with TNF inhibitors.  Tocilizumab is a humanized monoclonal antibody directed against the receptor for IL-6, […]

FDA Safety Review Recommends Updated Labeling for TNF Inhibitors

The U.S. Food and Drug Administration released revised requirements for the updating of the prescribing information for all currently licensed TNF inhibitors (etanercept, infliximab, adalimumab, golimumab, and certolizumab).  Based on a recent review of post-marketing safety data, the agency is mandating that prescribers be aware of an increased event rate for malignancies in children and […]