• Merck received a positive EU CHMP opinion recommending expansion of Enflonsia’s indication to children vulnerable to severe RSV disease.
• The expansion covers RSV lower respiratory tract disease prevention in high-risk children up to 24 months through their second RSV season.
• A European Commission decision is expected within two months, covering the EU, Iceland, Liechtenstein and Norway.
• The FDA accepted a supplemental application for children under two at increased risk, with a target decision date of March 22, 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Merck & Co. Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20261112997983) on November 13, 2026, and is solely responsible for the information contained therein.