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In a briefing document issued ahead of a two-day meeting by its vaccines advisory committee that begins today, the FDA indicated its support for Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for children age six months through four years. Read More
AstraZeneca is aiming to expand the use of its dual-antibody COVID-19 treatment Evusheld (tixagevimab–cilgavimab) to nonhospitalized patients with mild-to-moderate COVID 19 based on data from a late-stage study that showed it reduced the risk of progression to severe disease or death by 50 percent in a group of unvaccinated patients at high risk of poor outcomes. Read More
Merck’s COVID-19 pill Lagevrio (molnupiravir) not only reduced the risk of hospitalization or death in patients with mild-to-moderate COVID-19 by 32.1 percent, it also reduced the chance of needing acute care visits for weeks after treatment ended, researchers reported in the Annals of Internal Medicine. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee voted almost unanimously yesterday for Emergency Use Authorization (EUA) of a two-dose primary series of the Novavax COVID-19 vaccine. Read More
Johnson & Johnson (J&J) is pulling out of its COVID-19 vaccine supply contract with the troubled drug manufacturing plant, Emergent BioSolutions. Read More
Novavax goes before FDA’s Vaccines and Related Biologics Advisory Committee this week, seeking Emergency Use Authorization of its COVID-19 vaccine. Read More