Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Wellstat Therapeutics Xuriden (uridine triaceta...
Merck KGaA and Pfizer report that the Phase 3 JAVELIN gastric cancer trial did not meet its primary endpoint of superior overall survival with aveluma...
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Relypsas Veltassa (patiromer sorbitex calcium),...
An FDA webinar explains the principles underlying two new final guidances on when to submit a new 510(k) for changes to a medical device or to softwar...
FDA releases the FDA-483 issued following an inspection at Northridge Hospital Dignity Health sterile drug products production facility.
The HHS Inspector General has withdrawn a favorable advisory opinion for the Caring Voice Coalition funded by drug companies to help Medicare patients...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory Improvement Amendmen...
Rep. Louise Slaughter (D-NY) urges FDA to take stronger action to preserve the effectiveness of antibiotics and protect public health.