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...
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...
FDA extends to 5/22 the PDUFA priority review action date for Astellas fezolinetant to treat some menopausal vasomotor symptoms.
Communications experts tell the Associated Press FDA may have a hard time combating misinformation due to several factors, including its reputation an...
Federal Register notice: FDA sends to OMB an information collection extension entitled Biologics License Applications (BLAs) Procedures and Requiremen...
Federal Register notice: FDA revises an information collection entitled Premarket Notification 21 CFR Part 807, Subpart E.
