FDA Extends Review Period for Ruxolitinib in GVHD

February 7, 2019 – The FDA has added 3 months to the review period for a supplemental new drug application (sNDA) for ruxolitinib for the treatment of patients with acute graft-versus-host disease (aGVHD) who have had an inadequate response to corticosteroids, making the new action date May 24, 2019. The extension will allow ample time for the FDA to review additional data the agency requested from Incyte, the manufacturer of the JAK1/JAK2 inhibitor … (leggi tutto)