Fluzone Quadrivalent Influenza Vaccine Approved by FDA for Elderly

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

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 […]

Merck Plans to Up Production of Experimental Ebola Vaccine

Merck Plans to Up Production of Experimental Ebola Vaccine

In response to the current outbreak of Ebola in the Democratic Republic of the Congo (DRC) which began in August 2018, the World Health Organization (WHO) has declared the outbreak a Public Health Emergency of International Concern (PHEIC). There have been about 2,500 confirmed cases of Ebola in the DRC and at least 1,737 people have […]