FDA Approves Yeztugo as Injectable Product to Prevent HIV in Adults and Adolescents
Last week, Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir), the company’s injectable HIV-1 capsid inhibitor, for use as pre-exposure prophylaxis (PrEP). Yeztugo is not labeled a “vaccine” but is a pharmaceutical product intended to reduce the risk of acquiring human immunodeficiency virus (HIV) via sexual activity […]
FDA Licenses Moderna’s mNEXSPIKE COVID Shot for Individuals at High Risk for Severe COVID Disease
On May 30, 2025, the U.S. Food and Drug Administration (FDA) licensed mNEXSPIKE (mRNA-1283), a newly developed mRNA COVID-19 biologic for individuals who have previously received any COVID shots and are either 65 years of age or older, or between 12 and 64 years old with at least one underlying medical condition that increases their […]
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 […]