FDA Phases Out Emergency Authorization for Pemgarda

The government’s decision stems from a broader Department of Health and Human Services initiative to sunset emergency protocols for medical devices and biological products. Federal regulators determined that the public health circumstances necessitating these temporary measures have sufficiently abated to warrant a return to standard regulatory processes.

Invivyd board chairman Marc Elia characterized the shift as a necessary evolution, noting that emergency designation is not a substitute for full clinical approval. The company is currently engaged in active discussions with the FDA, seeking to leverage its existing safety and efficacy data to secure a full market authorization for the antibody treatment.