Managed Healthcare Executive July 16, 2022
In COVID-19 news, the FDA grants EUA for Novavax’s COVID-19 vaccine. The agency approved a novel diagnostic dye and another indication for Xalkori, but delayed a decision on a therapy for esophageal cancer. FDA has also accepted a BLA for advanced HER2 breast cancer therapy. Finally, Can-Fite BioPharma plans submission for psoriasis therapy.
FDA grants EUA for Novavax COVID-19 vaccine.
American adults have another COVID-19 vaccine option after the FDA granted emergency use authorization (EUA) for Novavax’s COVID-19 vaccine. In early June, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend the FDA grant EUA for the vaccine.
At the June 7, 2022, VRBPAC meeting, Novavax “heard the overwhelming support for...