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September 21, 2021
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.
FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.
Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.
Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.
The new FDA office will reorganize IT, data, and cybersecurity functions to an agency level.