Coronavirus Disease 2019 (COVID-19) Update

If your email program has trouble displaying this email, view as a webpage. FDA Office of Minority Health and Health Equity Coronavirus Disease 2019 (COVID-19) Updates Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last email update include: October 26, 2020: Daily roundup on an updated antigen template for test developers October 23, 2020: Updated FDA COVID-19 Response At-A-Glance Summary (PDF) October 22, 2020: FDA Approves First Treatment for COVID-19 October 22, 2020: Vaccines and Related Biological Products Advisory Committee - The Committee met in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. YouTube recording (8 hours, 50 minutes) Bookmark www.fda.gov/coronavirus for the latest. FDA approves first treatment for COVID-19 On October 22, 2020, FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. FDA revised the Emergency Use Authorization (EUA, PDF) for Veklury to remove those uses that are now approved under Gilead's New Drug Application (NDA). The EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Related links: FDA's approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness Frequently Asked Questions for Veklury (remdesivir), including information on additional clinical trials (PDF) Veklury (remdesivir) label (PDF)   Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter.   Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity

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