FDA denies a 10/2017 Novo Nordisk petition asking it not to approve any ANDA referencing any of the companys liraglutide-containing drugs as the refer...
Federal Register notice: FDA sends to OMB an information collection extension for Adverse Experience Reporting (AER) for Licensed Biological Products;...
FDA Review posts the Federal Register notices for the week ending 1/5/2018.
FDA commissioner Scott Gottlieb says production of critically needed drugs in Puerto Rico is improving and shortages may soon begin to ease.
FDA approves an Amgen supplemental BLA for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events...
BioCardia files an IDE for the CardiAMP Chronic Myocardial Ischemia Trial to treat patients with refractory angina.
FDA approves Roches cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing.
FDA clears a Mevion Medical Systems 510(k) clearance for the Mevion S250i Proton Therapy System that uses its Hyperscan pencil beam scanning technolog...