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The FDA’s Antimicrobial Drugs Advisory Committee, meeting Thursday, was overwhelmingly positive in its assessment of benefits and risks of AstraZeneca’s respiratory syncytial virus (RSV) preventive treatment, nirsevimab, for children. Read More
New FDA drug approvals in May include the first vaccine for respiratory syncytial virus, a hot flash treatment for menopausal women, a gene therapy for a rare skin disease and the first and only treatment for a rare hematologic disorder. Additionally, the FDA approved a next-generation sequencing-based companion diagnostic test for solid tumor profiling. Read More
Persisting first through an FDA complete response letter (CRL), and then through a denial of a formal dispute resolution request, Akebia Pharmaceuticals is now counting on Japanese postmarketing safety data to get vadadustat, its chronic kidney disease (CKD) anemia drug, over the finish line in the U.S. Read More
Medicare will pay for treatment with any antiamyloid antibody that is fully approved by the FDA and administered as part of a national registry run by CMS, according to the agency. Read More
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended pulling a Novartis sickle cell disease drug from the market and approving two others to diagnose prostate cancer and treat a certain form of epilepsy. Read More