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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
The Senate Health, Education, Labor and Pensions (HELP) Committee voted 13 to 9 yesterday in favor of a bill reauthorizing FDA user fees, advancing the package for a floor vote. 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 granted ReViral’s investigational antiviral drug, sisunatovir, Fast Track designation in August 2020 for treatment of serious RSV infections. 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
Vertex Pharmaceuticals’ and CRISPR Therapeutics reported positive follow-up data from two late-stage clinical trials showing continued benefit from using their gene-editing treatment for people with transfusion-dependent beta thalassemia (TDT) or severe sickle cell disease (SCD). 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Facing a rejection from Health Canada, Biogen has withdrawn its Canadian drug application for Aduhelm (aducanumab), marking another setback for the controversial Alzheimer’s disease treatment.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