Fluzone Quadrivalent Influenza Vaccine Approved by FDA for Elderly
The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (BLA) for the Fluzone high-dose quadrivalent influenza vaccine for use by adults 65 years of age and older. Fluzone is manufactured by Sanofi Pasteur, Inc. of France.1 2 The Fluzone high-dose influenza vaccine was approved by the FDA in 2009 as […]
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 […]
MMR Vaccine Sales Boost Merck’s 2019 Revenues
After the Centers for Disease Control and Prevention (CDC) publicized measles outbreaks in several states beginning in January 2019, on May 1 Merck & Co. announced that it had increased production of its live attenuated (weakened) virus MMR (measles, mumps, rubella) vaccine in response to an increasing demand for the product in the United States. […]
