USFDAJul 6, 2026, 07:17 AM
Invivyd Receives FDA Notice of PEMGARDA® EUA Termination
AI Summary
Invivyd, Inc. announced that the FDA issued a notice of termination for the Emergency Use Authorization (EUA) of its COVID-19 prophylactic, PEMGARDA®, effective June 29, 2027. This follows the U.S. Department of Health and Human Services' advanced notice of termination for the broader COVID-19 EUA declaration. Invivyd is actively engaging with the FDA to determine next steps and plans to pursue a Biologics License Application (BLA) for full approval of PEMGARDA, citing strong clinical and post-authorization data.
Key Highlights
- HHS announced advanced Notice of Termination of the COVID-19 EUA declaration, effective June 29, 2027.
- Invivyd received FDA Notice of Termination for PEMGARDA® EUA, effective June 29, 2027.
- The termination includes a twelve-month transition period.
- Invivyd is in dialogue with the FDA regarding appropriate next steps for PEMGARDA.
- Invivyd intends to pursue full Biologics License Application (BLA) approval for PEMGARDA.
- PEMGARDA was authorized under EUA in March 2024 for pre-exposure prophylaxis of COVID-19.
Price Impact
More from IVVD