9 June 2026 - Takeda today announced the US FDA has accepted for review its supplemental biologics license application for intravenous Entyvio (vedolizumab) for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in pediatric patients ages 2 years and older. 

If approved, Entyvio would be the only gut-focused treatment option for these patients. This milestone reflects Takeda's deep commitment to this patient community and its role in advancing care and addressing unmet needs in ulcerative colitis and Crohn's. The FDA has set a PDUFA goal date in the first quarter of calendar year 2027.

Read Takeda press release