FDA advisers endorse Remicade for children with ulcerative colitis

The benefit-risk profile of Johnson & Johnson's Remicade supports its approval for treating ulcerative colitis in children for whom other medications don't work, an FDA advisory panel concluded. However, panelists said additional data are warranted on the risk of cancer, particularly hepatosplenic T-cell lymphoma, and serious infections associated with Remicade and similar drugs.

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