Federal Register notice: FDA determines that Allergans Asacol HD (mesalamine) delayed-release tablet, 800 mg, was not withdrawn due to safety or effec...
Federal Register notice: FDA determined that Janssens Topamax (topiramate) sprinkle capsules, 50 mg, was not withdrawn due to safety or effectiveness ...
The Association for Accessible Medicines praises the FDA revision of a draft guidance on generic drug controlled correspondence to meet new GDUFA 3 ag...
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...
