Federal Register Notice: FDA’s Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 12/9, from 8 a.m. to 5:30 p.m. at the FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD. The committees will discuss two Millenium Pharmaceuticals’ BLAs for Entyvio vedolizumab injection for treating adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNF[alpha]) antagonist. BLA 125507 proposes an indication for treating adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a TNF[alpha] antagonist. Contact Cindy Hong, (301) 796-9001. To view this notice, click here