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The approval comes after a phase 3 trial of 5,674 patients in which Kerendia resulted in lower risks of CKD progression and cardiovascular events. Read More
The European Medicines Regulatory Network announced yesterday that it has adopted a common standard for the electronic product information (ePI) on medicines in the EU. Read More
FDA’s Office of Prescription Drug Promotion (OPDP) has issued a warning letter to precision medicine developer CytoDyn about a video interview found on the company’s corporate website. Read More
The FDA has announced that it found four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the troubled Emergent BioSolutions manufacturing facility in Baltimore, Md., to be acceptable for use for potential export. Read More
Newly confirmed and sworn-in FDA Commissioner Robert Califf spelled out some of his priorities in a Feb. 17 memo to the agency’s staff and repeated them in a series of tweets from his brand-new Twitter account — @DrCaliff_FDA. Read More
Collins and Nelson will help oversee the creation of the Advanced Research Projects Agency for Health, which will research treatments for serious ailments, including cancers, infectious diseases and Alzheimer’s disease. Read More