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42

FDA authorizes Pfizer’s COVID-19 vaccine booster for U.S. adults

The U.S. Food and Drug Administration on November 19 authorized booster doses of Pfizer Inc. and BioNTech SE’s Covid-19 vaccine for all adults, a move aimed at addressing waning protection among fully vaccinated Americans in the face of Delta variant-driven breakthrough cases of the illness.

44

Gilead Submits Biologics License Application to U.S. FDA for Bulevirtide

Gilead Sciences Inc. announced the submission of a Biologics License Application to the U.S. Food and Drug Administration for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease; bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA.