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.
FDA warns St. Paul, MN-based Fagron Group about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Federal Register notice: FDA makes available a final guidance entitled Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment.
Federal Register notice: FDA announces the approval of product that redeemed a priority review voucher AstraZencas sBLA for Ultomiris (ravulizumab-cw...
FDA says the GE Healthcare recall of its Carescape R 860 ventilator due to issues with its backup and replacement backup batteries is Class 1.
FDA releases an FDA-483 with six observations from an inspection at Lake Balboa, CA-based Expert Compounding Pharmacy, a producer of non-sterile drugs...