New York Attorney General Letitia James and a bipartisan coalition of 47 other attorneys general secure $17.85 million from drug manufacturers Bausch ...
FDA accepts for review an Exelixis NDA for zanzalintinib in combination with the immune checkpoint inhibitor atezolizumab for patients with previously...
FDA launches its new PreCheck pilot program aimed at strengthening domestic pharmaceutical manufacturing by providing earlier regulatory engagement an...
FDA issues Pharming Group a complete response letter for its supplemental NDA seeking expanded approval of Joenja (leniolisib) for children aged 4 to ...
FDA discontinues the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the proc...
Grail files the final module of its PMA for the companys multi-cancer early detection blood test.
FDA awards Biogen a breakthrough therapy designation for its experimental antibody litifilimab for treating cutaneous lupus erythematosus.
A group of Democratic senators ask HHS Office of Inspector General to clarify how it will oversee direct-to-consumer prescription drug sales tied to t...
