COVID-19 vaccine

Moderna has filed an FDA application for its Spikevax 2025-2026 formula specifically targeting the SARS-CoV-2 variant LP.8.1, following FDA guidance to update COVID-19 vaccines to a monovalent JN.1 lineage.

The FDA has ordered Pfizer and Moderna to expand warning labels on their COVID-19 vaccines regarding myocarditis and pericarditis risk, particularly in males aged 16-25, with an incidence rate of 38 cases per million doses.

The FDA has announced major changes to COVID-19 vaccine approvals, requiring placebo-controlled clinical trials for shots intended for healthy adults and children, effectively ending routine annual approvals for these groups.

The FDA has requested an additional clinical trial for Novavax's protein-based COVID-19 vaccine (NVX-CoV2601) before granting full approval, despite promising Phase 2/3 results showing a 5.8-fold increase in neutralizing antibodies.

Eli Lilly's once-daily oral GLP-1 receptor agonist, orforglipron, demonstrated statistically significant efficacy and a safety profile consistent with injectable GLP-1 medicines in a successful Phase 3 clinical trial.