FDA notifies Invivyd that Pemgarda EUA will end June 2027

Go back to FDA notifies Invivyd that Pemgarda EUA will end June 2027

Invivyd Announces Receipt of Twelve Months’ Advanced Notice of Emergency Use Authorization (EUA) Termination for PEMGARDA® and Provides an Update on Next Steps with the U.S. FDA

July 6, 2026 7:01 AM EDT

U.S. Department of Health and Human Services (HHS) announced advanced Notice of Termination of the COVID-19 EUA declaration, effective June 29, 2027 Consequently, Invivyd received from the U.S. Food and Drug Administration (FDA) Notice of Termination of the PEMGARDA EUA, to be effective on June 29, 2027, after a twelve-month transition periodConsistent with EUA transition processes, Invivyd is in dialogue with FDA about appropriate next steps for PEMGARDAInvivyd intends to pursue every avenue to secure permanent, high quality medical protection from COVID infection for immune-compromised and other vulnerable Americans... More