The US Food and Drug Administration (FDA) on Friday released a new emergency use authorization (EUA) template to assist test makers in developing at-home sample collection kits for use with tests for ...

Abbott has scored yet another Emergency Use Authorization for rapid coronavirus testing – this one, named BinaxNOW COVID-19 Ag Card, come in the form of a card and can provide results in 15 minutes.

FDA issues EUA for saliva-based COVID-19 test, provides path for wider home sample collection The US Food and Drug Administration (FDA) on Friday granted the first emergency use authorization (EUA) ...

Invivyd, Inc. announced the submission of an updated immunobridging analysis to the FDA, aimed at supporting an amendment to the Emergency Use Authorization (EUA) for its investigational monoclonal ...

Pfizer and BioNTech have officially requested that their COVID-19 vaccine be cleared for use among young children. In a tweet Thursday, Pfizer said the companies submitted their request for an ...

On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to ...

With the FDA granting emergency use authorization (EUA) to Invivyd’s lead candidate, a monoclonal antibody (mAb) designed to prevent COVID-19 in immunocompromised adults and adolescents, the company ...

This high-volume laboratory test will allow for collection of blood samples using a simplified proprietary blood collection device once cleared by the FDA. IRVINE, Calif., June 16, 2020 (GLOBE ...

On Monday, the FDA declined Invivyd, Inc.’s (NASDAQ:IVVD) request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for Pemgarda (pemivibart) for ...

The FDA has issued its first emergency use authorization for a COVID-19 molecular diagnostic test that does not require a prescription and can be used at home. Developed by Cue Health, the Cue ...