FDA publishes three guidances on aspects of x-ray system regulation.
FDA will give priority review with a decision expected this year on a Pfizer BLA for elranatamab to treat some multiple myelomas.
FDA expands its warning against using specific artificial tears products to now include Delsam Pharmas Artificial Eye Ointment due to potential bacter...
FDA clears a RapidAI 510(k) for Rapid RV/LV, a tool for physicians to quickly assess the ratio between the right ventricle and the left ventricle to d...
The U.S. Supreme Court declines to hear a Johnson & Johnson case that sought the high courts review and reversal of a California Court of Appeal decis...
Federal Register notice: FDA announces a 4/25 public meeting entitled Patient-Focused Drug Development for Long Covid.
FDA accepts for priority review a Regeneron BLA for pozelimab to treat CHAPLE disease in children and adults.
FDA says Office of New Drugs director Peter Stein will decide an Akebia Therapeutics formal dispute resolution request over the complete response lett...
