The FDA Sent Invivyd An Advance Termination Notice For Pemgarda (Pemivibart) Emergency Use Authorization Following US Department Of Health A

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 period Consistent with EUA transition processes, Invivyd is in dialogue with FDA about appropriate next steps for PEMGARDA Invivyd intends to pursue every avenue to secure permanent, high quality medical protection from COVID infection for immune-compromised and other vulnerable Americans PEMGARDA has demonstrated strong protection from COVID in a contemporary randomized clinical trial, has been growing in clinical use for more than two years, and is a critical non-vaccine option for vulnerable Americans that combines high antiviral activity and attract...