New reporting finds that the White House recently requested the resignation of a senior aide to FDA commissioner Marty Makary, highlighting growing fr...
Three Harvard medical professors raise concerns over FDAs review voucher program that they say could politicize drug approvals and undermine scientifi...
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 issues an untitled letter to SK Life Science, raising concerns over a direct-to-consumer television advertisement for its seizure medication Xcopr...
FDA approves Mercks checkpoint inhibitor Keytruda (pembrolizumab) in combination with Astellas and Pfizers antibody drug conjugate Padcev as a periop...
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...
Intersurgical recalls (Class 1) its i-View Video Laryngoscope, citing serious safety risks that could potentially lead to severe injury or death.
