FDA issues a white paper outlining issues to be discussed at a December workshop on the distinctions between medical device servicing and remanufactur...
FDA clears a Rocky Mountain Orthodontics 510(k) for Orthocaps, a transparent and removable appliance for correcting tooth malpositions.
Pfizer and Lilly say a Phase 3 trial of their novel osteoarthritis monoclonal antibody met all three co-primary efficacy endpoints.
FDA approves Genentechs Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and older.
Federal Register notice: FDA announces a 12/17 joint advisory committee meeting to discuss strategies to increase the availability of naloxone product...
A new study concludes that the FDA Amendments Act (FDAAA) of 2007 has led to more clinical trials being registered and results being reported on Clini...
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Imclones Lartruvo.
FDA publishes a draft guidance to assist sponsors who develop drug products that may result in testicular toxicity.