Posted by Michael Wonder on 03 Sep 2025
FDA accepts Shionogi’s ensitrelvir NDA as the first oral therapy for the prevention of COVID-19 following exposure
2 September 2025 - Shionogi announced the US FDA has accepted a new drug application for ensitrelvir fumaric acid, an investigational oral anti-viral, for the prevention of COVID-19 following exposure to an infected individual.
The FDA has set an action date of 16 June 2026 under the Prescription Drug User Fee Act.
