FDA Approves Novavax’s COVID-19 Vaccine With Restrictions
On May 16, 2025, the U.S. Food and Drug Administration (FDA) approved licensure of Novavax, Inc.’s Nuvaxovid protein-based COVID-19 vaccine, which has been available in the United States under Emergency Use Authorization (EUA) since July 2022.1 The decision for a full licensure was postponed while the new agency leadership under the current administration conducted a […]
FDA, CDC Halt Use of Chikungunya Vaccine in Adults 60+ After Two Deaths Reported
On May 9, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) recommended a temporary pause in the use of Ixchiq, a live virus vaccine designed to prevent chikungunya virus infection, in adults aged 60 years and older. The recommendation follows reports of serious post-marketing adverse […]
Guillain-Barré Syndrome Warning Added to Shingrix Vaccine in Australia
In February 2024, Australia’s Therapeutic Goods Administration (TGA), the country’s national regulatory authority for drugs and, initiated an investigation into a potential association between GSK plc’s Shingrix shingles vaccine, Guillain-Barré syndrome (GBS), which causes inflammation and damage to the nerves, that may include paralysis.1 The investigation was prompted by two reports of GBS following Shingrix […]
Pfizer Ends Development of Weight-Loss Pill After Liver Injury in Trial Participant
Pfizer, Inc. announced that it is discontinuing development of its experimental daily weight loss pill after a trial participant suffered a liver injury potentially linked to the drug. The company confirmed that the oral GLP-1 drug, danuglipron (PF-06882961), is no longer in development following the incident.1 Pfizer has been studying danuglipron since 2022.2 A Pfizer […]
Swedish Study Investigates Food Allergy Increases in Children But Big Questions Remain
An estimated 1 in 13 children in the United States now have food allergies, a 50 percent increase in the incidence of food allergies between 1997 and 2011. Food allergy researchers have suggested there are several factors contributing to this increase, including shifts toward more processed diets, insufficient levels of vitamin D from limited sun […]
FDA Recalls Acne Products Contaminated with Benzene Carcinogen
On Mar. 11, 2025, the U.S. Food and Drug Administration (FDA) alerted the public and industry about the results of its recent testing on 95 over-the-counter acne products containing benzoyl peroxide for possible contamination with benzene, a carcinogen. The agency determined that a limited number of acne products should be recalled from retail shelves.1 Human […]