FDA warns IDA Australia about CGMP deviations and violations in its production of active pharmaceutical ingredients and finished drugs.
FDA accepts for priority review a Genentech supplemental BLA for Hemlibra (emicizumab-kxwh) for adults and children with hemophilia A without factor V...
FDA approves Eli Lillys Alimta (pemetrexed for injection) in combination with carboplatin and Mercks Keytruda (pembrolizumab) for the initial treatmen...
FDA executives say the agency is developing new pharmacovigilance techniques as part of its response to the nations opioid crisis.
FDA releases its latest batch of Warning Letters that include Fertility Partnership, IDT Australia Ltd., and Kolmar Korea Co. Ltd.
FDA finishes its review of a Medifocus Prolieve post-approval study that the company says confirms the treatments long-term safety, efficacy, and dura...
FDA clears an EOS Imaging 510(k) for its hipEOS 3.0 surgical planning software.
FDA clears a Royal Philips 510(k) for the Ingenia Elition 3.0T magnetic resonance (MR) device and two clinical applications, Philips Compressed SENSE ...