Invivyd's lead monoclonal antibody product, Pemgarda, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for the pre-exposure prophylaxis of COVID-19 in certain vulnerable populations. While an EUA permits commercial distribution and clinical use under specific emergency declaration criteria, it differs from traditional full FDA approval, which requires more extensive, long-term review data. The company continues to gather clinical trial data and engage with regulatory bodies to support ongoing developmental milestones and future regulatory submissions across its broader therapeutic pipeline.