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September 21, 2021
US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.
The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.
AstraZeneca will establish an API manufacturing facility near Dublin, Ireland.
The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.
Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.
September 20, 2021
FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.
September 17, 2021
UCR scientists are researching whether a plant-based messenger RNA vaccine can be created and aim to eliminate the need for the refrigeration of mRNA vaccines during transport and storage.
People with ulcerative colitis who are taking statins were found to have a 50% decreased risk of colectomies and hospitalization, according to a Stanford Medicine study.
Pfizer has expanded its voluntary recall to include all lots of varenicline (Chantix), but FDA allows continued distribution of the drug product to continue due to drug shortages.
Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.