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On the heels of unanimous recommendations last week by its vaccines advisory committee, the FDA granted Emergency Use Authorization (EUA) on Friday for Moderna’s COVID-19 vaccine for children between six months and 17 years and for Pfizer-BioNTech’s COVID-19 vaccine for children between six months and four years. Read More
The Medicines Patent Pool (MPP) has inked a patent-sharing agreement with South African pharmaceutical company Biotech Africa to accelerate the manufacturing and sale of a COVID-19 antibody test. Read More
An annual report from the FDA’s Center for Drug Evaluation and Research (CDER) says the agency’s drug manufacturing inspection activities fell short of CDER’s self-determined goals in fiscal year 2021, primarily due to COVID-related restrictions. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 21-0, yesterday in favor of FDA emergency authorization for Moderna’s two-dose COVID-19 vaccine series in children between age six months and five years and Pfizer’s three-dose COVID-19 vaccine series in children between age six months and four years. Read More
Due to a very low rate of hospitalization or death observed in the standard-risk patient population, Pfizer has decided to end enrollment in the study. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 22-0, yesterday to recommend FDA authorization of Moderna’s two-dose primary series of its COVID-19 vaccine for children between the ages of 12 and 17 and between six and 11. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) is looking past the pandemic in its current goals for 2022, says Director Patrizia Cavazzoni, focusing on initiatives on rare diseases, real-world data (RWD), supply chain surveillance and increased patient engagement in drug development. Read More