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 […]
FDA Bans Red No. 3 Used in Many Processed Foods
The artificial coloring known as Red Dye No. 3 has been banned in cosmetics in the U.S. for 35 years, but it has been allowed to stay in food and medicine. The synthetic dye that gives foods a cherry red color is an ingredient in more than 9,200 products on store shelves in the country. […]
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 […]
Moderna Halts RSV Pediatric Vaccine Trial After Five Infants Hospitalized
On Dec. 11, 2024, the U.S. Food and Drug Administration (FDA) announced that clinical trials for Moderna’s pediatric mRNA RSV vaccines have been paused due to safety concerns. The recent phase 1 trials of two experimental respiratory syncytial virus (RSV) vaccines for infants not only failed to provide adequate protection but may have worsened respiratory […]
First Severe Case of Human Bird Flu Confirmed in U.S.
Officials at the U.S. Centers for Disease Control and Prevention (CDC) have confirmed diagnosis of the first severe human case of “bird flu” or H5N1 avian influenza. They determined that the hospitalized patient, a resident of Louisiana, was exposed to “sick and dead birds in backyard flocks,” although the source of the infection in the […]