FDA warns operators of 53 Web sites to stop illegally selling opioids.
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...
Federal Register notice: FDA issues a proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast les...