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Invivyd: PEMGARDA EUA 2027년 6월 29일 종료
FDA가 COVID-19 EUA 선언의 HHS 종료에 따라 PEMGARDA EUA 종료 통지를 발행했으며, 2027년 6월 29일부터 효력이 발생합니다. 회사는 FDA와 다음 단계에 대해 논의 중이지만 BLA 경로에 대한 서면 조언을 아직 받지 못했습니다.
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EX-99.1 2 ivvd-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 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 • 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