FDA issues an untitled letter to SK Life Science, raising concerns over a direct-to-consumer television advertisement for its seizure medication Xcopr...
Former FDA principal deputy commissioner Janet Woodcock and policy experts from Duke University call on the agency to adopt new tools and pathways to ...
FDA investigates the death of a pediatric patient with congenital thrombotic thrombocytopenic purpura who developed neutralizing antibodies to the enz...
FDA investigators cite Immacule Lifesciences Private Limited, a sterile drug contract manufacturer in Himachal Pradesh, India, for extensive lapses in...
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.
Politico reports that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are feuding over vaccine safety studies and staffing app...
FDA says the Medline 8/22 recall of three models of surgical convenience kits that were not sterilized is Class 1.
