The Justice Department indicts generic drug manufacturer KVK-Tech and two executives on charges of defrauding FDA based on their alleged distribution ...
FDA releases more information concerning Janssens Covid-19 contaminated vaccine substance made at Emergent BioSolutions troubled contract manufacturin...
Two recent facility inspections of Innova Medical Group result in a 6/10 Warning Letter because the firm is marketing its SARS-CoV-2 Antigen Rapid Qua...
Gaithersburg, MD-based Novavax says its recombinant nanoparticle protein-based Covid-19 vaccine demonstrated 100% protection against moderate and seve...
Former FDA commissioner Stephen Hahn joins Flagship Pioneering as chief medical officer of its preemptive medicine and health security initiative.
FDA sends Avenue Therapeutics a second complete response letter on its NDA for an intravenous formulation of tramadol, indicated for treating patients...
FDA Review posts the Federal Register notices for the week ending 6/11/2021.