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FDA Declined Invivyd’s Request to Expand Existing Emergency Use Authorization of PEMGARDA™ (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For Immunocompromised Persons Who ...

Invivyd, Inc.  (IVVD) 
PDF FDA’s reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral [Read more]