New reporting finds that the White House recently requested the resignation of a senior aide to FDA commissioner Marty Makary, highlighting growing fr...
Intersurgical recalls (Class 1) its i-View Video Laryngoscope, citing serious safety risks that could potentially lead to severe injury or death.
Three Harvard medical professors raise concerns over FDAs review voucher program that they say could politicize drug approvals and undermine scientifi...
FDA posts a Federal Register notice finalizing the withdrawal of Intercept Pharmaceuticals Ocaliva (obeticholic acid) from the U.S. market for treatin...
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...
FDA approves Mercks checkpoint inhibitor Keytruda (pembrolizumab) in combination with Astellas and Pfizers antibody drug conjugate Padcev as a periop...
FDA issues an untitled letter to SK Life Science, raising concerns over a direct-to-consumer television advertisement for its seizure medication Xcopr...
Politico reports that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are feuding over vaccine safety studies and staffing app...