FDA clears a Levita Magnetics 510(k) for an expanded indication to market the companys Levita Magnetic Surgical System for use in bariatric procedures...
FDA approves Regenerons Dupixent dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with a...
FDA Review posts the Federal Register notices for the week ending 10/19/2018.
Federal Register notice: FDA makes available a draft guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Pro...
FDA updates a safety communication to reduce potential cardiac surgery infection risks associated with the LivaNova 3T Heater-Cooler Systems.
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for SK Chemicals Afstyla.
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Regeneron Pharmaceuticals Dupixent.
Federal Register notices: FDA makes available six medical device classification orders.