Novartis Manipulated Data in FDA Biologics License Application
On Aug. 6, 2019, the U.S. Food and Drug Administration (FDA) issued a statement saying that Swiss pharmaceutical company Novartis AG submitted a biologics license application (BLA) for the spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi) with manipulated data and failed to inform regulators until June 28, 2019—more than a month after the […]
