Three Harvard medical professors raise concerns over FDA’s review voucher program that they say could politicize drug approvals and undermine scientific standards.
FDA posts a Federal Register notice finalizing the withdrawal of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis due to liver injury concerns.
Three Harvard medical professors raise concerns over FDA’s review voucher program that they say could politicize drug approvals and undermine scientific standards.
FDA posts a Federal Register notice finalizing the withdrawal of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis due to liver injury concerns.
FDA issues a correction notice for NOxBOX Ltd.’s NOxBOXi Nitric Oxide Delivery System after reports of dosing fluctuations when the device is used with conventional ventilators.
FDA approves Merck’s checkpoint inhibitor Keytruda (pembrolizumab) —in combination with Astellas and Pfizer’s antibody drug conjugate Padcev — as a perioperative treatment for adults with muscle-invasive bladder cancer.
