US FDA

Yeztugo’s twice-yearly injection aims to overcome these obstacles by reducing the frequency of dosing and potentially lowering stigma associated with daily medication.

This oral, pangenotypic direct-acting antiviral (DAA) therapy is now available to treat both adults and children from the age of three who have either acute or chronic hepatitis C virus (HCV) infection.

The vaccine is now authorized for use in individuals aged 18 to 59 who are at increased risk for RSV-related lower respiratory tract disease (LRTD).

The safety signal that triggered the FDA’s hold indicates a potential immune system compromise, as reductions in CD4+ T-cells can signal a worsening of HIV infection.

One notable advantage of mNEXSPIKE is its lower dose—one-fifth that of Spikevax—which may contribute to fewer side effects and easier manufacturing.

This decision aligns with a similar move by the European Medicines Agency (EMA) on May 7, which suspended the vaccine’s use in adults aged 65 and above, as well as in those with weakened immune systems, while conducting an ongoing safety review.

Steele replaces Julie Tierny, who briefly served as the acting director following Marks’ resignation, a departure characterized by controversy, as he criticized Health and Human Services Secretary Robert F. Kennedy Jr. for spreading misinformation about vaccine efficacy and safety.

Marks has been a pivotal figure at the FDA since 2016, overseeing the regulation of vaccines, allergenic products, blood products, and cellular, tissue, and gene therapies.

Unlike traditional treatments that replace missing clotting factors, Qfitlia functions by reducing levels of antithrombin, a protein that hinders blood clotting.