FDA grants accelerated approval for Bristol-Myers Squibbs Opdivo and Yervoy in hepatocellular carcinoma patients who were previously treated with Baye...
FDA approves a Roche PMA for its CINtec Plus Cytology as a biomarker-based triage test for women whose primary cervical cancer screening results are p...
Lawmakers at an FDA appropriations hearing criticize commissioner Stephen Hahn about delays in coordinating laboratory-developed tests and the agencys...
FDA issues an ICH guidance on limiting elemental impurities in drug products.
Federal Register notice: FDA announces a 5/4 public workshop entitled FY 2020 Generic Drug Regulatory Science Initiatives.
Federal Register notice: FDA withdraws approval of 16 ANDAs from multiple applicants after they notified the agency that their drug products were no l...
Federal Register notice: FDA makes available a draft guidance entitled Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glyc...
FDA publishes a draft guidance recommending ways to provide regulatory submissions