Treatment of moderately to severely active Crohn's disease for the reduction of signs and symptoms, and the induction and maintenance of sustained response and remission, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or are intolerant to or have medical contraindications to such therapies.
TYSABRI — BIOGEN IDEC, approved 2025-03-18 (BLA125104).
132,149 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.