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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
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
Facing a rejection from Health Canada, Biogen has withdrawn its Canadian drug application for Aduhelm (aducanumab), marking another setback for the controversial Alzheimer’s disease treatment. Read More
The European Medicines Agency’s (EMA’s) safety committee has recommended the withdrawal of EU marketing authorization for amfepramone obesity medicines after a review showed that “their benefits do not outweigh their risks.” Read More
The FDA’s Center for Biologics Evaluation and Research (CBER) said it plans to resume normal operations starting calendar year 2023 following the more than two-year focus on COVID-19, which seriously impacted the center’s operations. Read More
Forty-nine states that are suing more than 20 generic drugmakers over alleged price-fixing can’t force the companies to hand over the profits of their alleged scheme as punishment, a federal judge has determined. Read More
An FDA advisory committee voted unanimously, 13 to 0, on Friday to recommend Bluebird Bio’s investigational gene therapy betibeglogene autotemcel (beti-cel) for patients with beta-thalassemia who require regular red blood cell transfusions. Read More