Johnson & Johnson discontinues its Auτonomy Phase 2b Alzheimers study after interim data showed its experimental antibody posdinemab failed to pr...
FDA cites PharmaTher over alleged misleading promotional claims for its generic ketamine.
Novo Nordisk says data from two global Phase 3 trials of semaglutide (Ozempic and Wegovy) have failed to slow clinical progression in adults with earl...
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.
