FDA warns drug manufacturers of non-sterile, water-based drug products that there have been the subject of recent product recalls due to Burkholderia ...
FDA expands the approved use of Hoffman La Roches subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis.
FDA Review posts Federal Register notices for the week ending 5/12/2017.
FDA releases the FDA-483 issued following a 2016 inspection at Japans Sekisui Medical API manufacturer.
Newly sworn-in FDA commissioner Scott Gottlieb visits Capitol Hill for his first testimony as the agency head 5/25 during a House budget hearing.
FDA classifies as Class 1 an Abbott recall of specific lots of three catheters NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatati...
FDA grants a breakthrough therapy designation to GlycoMimetics for GMI-1271 and its use in treating adult relapsed/refractory acute myeloid leukemia.