Federal Register notice: FDA withdraws the approval of 20 NDAs from multiple applicants after they notified the agency that the drug products were no ...
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for MedImmunes Imfinzi (durvalumab), indica...
Former FDA Associate Chief Counsel for Enforcement Beth Weinman joins Ropes & Gray at its Washington, D.C. office as counsel in the firms life science...
FDA announces a voluntary Optical Coherence Tomography Premarket Notification (510(k)) Pilot Program, which is intended to develop and refine individu...
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Federal Register notice: FDA makes available a draft guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Pro...