FDA accepts an Amag Pharmaceuticals NDA for bremelanotide, a first-in-class melanocortin 4 receptor agonist for treating hypoactive sexual desire diso...
FDA clears a Rodo Medical 510(k) for the Rodo Smilekey, an induction remover device for use with the Rodo Abutment System.
FDA estimates 2017 generic drug approval cost-savings at $8.8 billion.
FDA warns South Koreas Kolmar Korea Co. about CGMP violations in its production of finished pharmaceuticals.
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...