FDA launches its new PreCheck pilot program aimed at strengthening domestic pharmaceutical manufacturing by providing earlier regulatory engagement an...
A patient safety advocacy group files a citizen petition urging FDA to create a comprehensive public database of medical device labels.
Floridas FDA-authorized drug importation program stalls and has yet to deliver any imported medicines more than two years after receiving final agency...
FDA sends Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating Type I allergic react...
New York Attorney General Letitia James and a bipartisan coalition of 47 other attorneys general secure $17.85 million from drug manufacturers Bausch ...
FDA issues Pharming Group a complete response letter for its supplemental NDA seeking expanded approval of Joenja (leniolisib) for children aged 4 to ...
FDA issues Beta Bionics a Warning Letter following an inspection of the companys Irvine, CA, facility conducted 6/2025.
FDA accepts for review an Exelixis NDA for zanzalintinib in combination with the immune checkpoint inhibitor atezolizumab for patients with previously...
