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The FDA has withdrawn its Emergency Use Authorization (EUA) for the GlaxoSmithKline and Vir Biotechnology COVID-19 monoclonal antibody treatment sotrovimab based on data indicating that it isn’t effective against the Omicron BA.2 subvariant. Read More
In one of his first public presentations as FDA commissioner, Robert Califf outlined his vision for enhanced use of health data as the way to improve health outcomes. Read More
The Office of Inspector General (OIG) within the Department of Health and Human Services has called for the increased use of biosimilars to reduce spending by the federal government’s Medicare Part D prescription drug program. Read More
Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will attempt to grapple with the problem of SARS-CoV-2’s vexing ability to escape vaccine coverage. Read More