Abbott seeks U.S. and E.U. approvals for Humira as a treatment for juvenile rheumatoid arthritis (News-Medical-Net)
Abbott has announced it has simultaneously submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA (adalimumab) as a treatment for juvenile rheumatoid arthritis (JRA) in the U.S. and juvenile idiopathic arthritis (JIA) in the European Union (EU).

FDA Advisory Panel Reviews DOR BioPharma's orBec(R) for Treatment of GI GVHD (Market Wire via Yahoo! Finance)
DOR BioPharma, Inc. announced today that the Oncologic Drugs Advisory Committee ("ODAC") appointed by the U.S. Food and Drug Administration voted that the data supporting orBec did not show substantial evidence of efficacy by a margin of 7 to 2 for the treatment of gastrointestinal graft-versus-host disease. The FDA is not bound by ODAC's recommendations, but it will take the panel's advice ...