Floridas FDA-authorized drug importation program stalls and has yet to deliver any imported medicines more than two years after receiving final agency...
FDA issues Beta Bionics a Warning Letter following an inspection of the companys Irvine, CA, facility conducted 6/2025.
FDA sends Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating Type I allergic react...
A patient safety advocacy group files a citizen petition urging FDA to create a comprehensive public database of medical device labels.
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 ...
