Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compounded forms of its sema...
FDA lifts a clinical hold against GH Researchs investigational antidepressant GH001, clearing the way for patient enrollment in the U.S. and advancing...
FDA alerts healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after manufacturer Vantiv...
Former FDA oncology drug leader Richard Pazdur says concerns surrounding a controversial fast-track drug review initiative under commissioner Marty Ma...
The U.S. Supreme Court agrees to hear a patent-infringement dispute between generic drugmaker Hikma Pharmaceuticals USA, Inc. and brand-name company A...
FDA inspectors cite Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures during a recent inspect...
FDA grants Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogrens disease.
Johnson & Johnson reports positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli significantly improv...
