BAVIS_1170X120_10-19-20

Dr. Stephen Hahn

FDA clears Moderna vaccine for COVID-19

FDA clears Moderna vaccine for COVID-19

WASHINGTON — The Food and Drug Administration formally authorized a second vaccine for emergency use from Moderna. The biotech upstart won authorization for use in adults following extensive federal analysis of the vaccine, which the FDA found to be 94% effective at preventing the disease. “With the availability of two vaccines now for the prevention of

FDA authorizes antigen test as first O-T-C fully at-home diagnostic test for COVID-19

FDA authorizes antigen test as first O-T-C fully at-home diagnostic test for COVID-19

WASHINGTON — The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (O-T-C) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments

Today’s FDA panel meeting could lead to Pfizer getting vaccine emergency use okay

Today’s FDA panel meeting could lead to Pfizer getting vaccine emergency use okay

WASHINGTON — Commissioner Stephen Hahn said ahead of  today’s meeting of the Food and Drug Administration’s vaccine advisory panel is “an important day for all of America.” Pfizer’s COVID-19 vaccine faces one last hurdle as it races to become the first shot greenlighted in the U.S. — a panel of experts who will carefully scrutinize

FDA finalizes enforcement policy on flavored cartridge-based e-cigarettes

FDA finalizes enforcement policy on flavored cartridge-based e-cigarettes

SILVER SPRING, Md. — Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration has issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease

Dr. Stephen Hahn confirmed as FDA Commissioner

Dr. Stephen Hahn confirmed as FDA Commissioner

WASHINGTON — The United States Senate voted, 72-18, on Thursday to confirm Dr. Stephen Hahn as Commissioner of Food and Drugs. Health and Human Services Secretary Alex Azar issued the following statement: “I congratulate Dr. Hahn and thank the Senate for prioritizing his nomination. President Trump has chosen a superbly qualified leader for FDA, and