FDA Official Leaves Agency Through the “Revolving Door” and Returns to Pfizer
On Feb. 24,2025, Pfizer, Inc. announced that FDA official Patrizia Cavazzoni, MD will rejoin the pharmaceutical company, which makes and sells federally recommended vaccines and drugs, as Pfizer’s Chief Medical Officer and Executive Vice President. Most recently, Dr. Cavazzoni served as Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food […]
FDA Approves GSK’s 5-in-1 Meningococcal Vaccine
On Feb. 14, 2025, British pharmaceutical and biotechnology company GSK plc announced that the U.S. Food and Drug Administration (FDA) approved its 5-in-1 meningococcal vaccine PENMENVY for licensure and use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of the bacterium Neisseria meningitidis (A, B, C, W, and Y), which […]
FDA Clears Investigational New Drug Application for Inhaled COVID Biologic
Biotech company Ocugen, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared their Investigational New Drug (IND) application for a novel inhaled vaccine against SARS-CoV-2. The biologic uses novel chimpanzee adenovirus-vectored (ChAd36) technology. The approval will allow the company to initiate Phase I clinical trials for the inhaled vaccine, OCU500. The […]
Atrial Fibrillation Linked to Age, COVID-19 and Vaccination on the Rise
Previous research has indicated that approximately 3 million people in the United States have atrial fibrillation (AFib); however, a 2024 study conducted by researchers from the University of California, San Francisco and published in the Journal of the American College of Cardiology has found that AFib is actually three times more prevalent in the U.S. […]
COVID-19 Shot Safety, Efficacy Concerns Exposed by Florida Grand Jury
While recent news headlines proclaim that a Florida Grand Jury has found no evidence of crimes committed by the manufacturers of COVID-19 shots, the actual report published earlier this month paints a more thorough picture. Two years after Florida’s Governor Ron DeSantis called for a federal investigation into the experimental mRNA COVID biologics for “any […]
FDA Requires RSV Vaccine Labels to Include Guillain-Barré Syndrome Risk
On Jan. 7, 2025, the U.S. Food and Drug Administration (FDA) mandated and approved changes to the safety labeling for the Prescribing Information of two Respiratory Syncytial Virus (RSV) vaccines: Abrysvo (manufactured by Pfizer)1 and Arexvy (manufactured by GlaxoSmithKline Biologicals).2 This label change update is being required to inform both the public and health care […]