FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients. “First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States.

The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 1-3 PM (EST) entitled “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology to identify areas of conceptual