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FDA Authorizes Revisions to Fact Sheets to Address SARS-CoV-2 Variants for Monoclonal Antibody Products Under Emergency Use Authorization

The U.S. Food and Drug Administration (FDA) authorized revised fact sheets for healthcare providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an Emergency Use Authorization (EUA) for the treatment of COVID-19. FDA is providing this information to equip healthcare providers with the

By |2021-03-24T20:24:55+00:00March 24th, 2021|alerts|Comments Off on FDA Authorizes Revisions to Fact Sheets to Address SARS-CoV-2 Variants for Monoclonal Antibody Products Under Emergency Use Authorization

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and

By |2021-03-02T15:55:54+00:00March 2nd, 2021|alerts|Comments Off on FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine