The HHS Inspector General says FDA agrees with its recommendations to improve foreign for-cause drug inspections.
FDA clears an Invictus Sterilization 510(k) for the Aura Storm ultraviolet medical air purifier that is intended to inactivate bacteria and viruses (e...
Santhera Pharmaceuticals says that a planned NDA submission for vamorolone in Duchenne muscular dystrophy has been postponed by four to six months aft...
Some 100 members of Congress call on HHS to use existing legal authorities to lower drug prices in the U.S.
University of Colorado researchers say they have identified two FDA-approved drugs that may help prevent Alzheimers disease and improve cognition in A...
Federal Register notice: FDA makes available a final guidance entitled Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment....
An FDA complete response letter says a Spero Therapeutics NDA for tebipenem HBr tablets to treat adults with complicated urinary tract infections cann...
FDA warns Irving, TX-based Re-Gen Active Lab about multiple violations in its production and marketing of several cellular-based drug products.