A third dose of Pfizer/BioNTech’s COVID-19 vaccine is authorized for kids ages 5 to 11 years, the FDA announced on Tuesday. The third 10 μg dose may be administered to children at least 5 months after the initial primary series under the terms of the emergency use authorization (EUA), the agency […]
Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: Hospitalized, or Not hospitalized and have […]
Today, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action […]
The FDA today announced its vaccines advisory committee will meet April 6 to discuss the future of COVID-19 booster doses and how to tell if a specific strain of the coronavirus needs its own vaccine. The independent experts on the Vaccines and Related Biological Products Advisory Committee will be joined by representatives […]
The US Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee has chosen the influenza vaccine strains for the 2022–2023 season in the northern hemisphere, which beginnings in the fall of 2022. On March 3, the committee unanimously voted to endorse the World Health Organization’s (WHO’s) recommendations as to which influenza […]
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age […]
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age […]
Plans to attempt to authorize the Pfizer/BioNTech Covid vaccine for children under 5 before full data are available appear to have run aground. The Food and Drug Administration on Friday canceled a key meeting of its vaccines advisory committee that had been slated for next Tuesday to discuss the submission, […]
The Food and Drug Administration has approved the first injectable pre-exposure prophylaxis (PrEP) medication to lower the risk of getting HIV through sex, the agency announced on Monday. Previously, PrEP had only been available in pill form. The new medication, called Apretude (cabotegravir extended-release injectable suspension) is given first as two injections one […]
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The […]
