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Best-selling medicines and drugs cleared under an FDA accelerated approval nab the most FDA-approved new formulations, and this translates to more costs for insurance plans and patients, according to an analysis in the journal JAMA Health Forum. Read More
The FDA has approved use of Celgene’s chemotherapy Vidaza (azacytidine) in advance of stem cell transplant for children newly diagnosed with a rare form of leukemia. Read More
The FDA has approved Eli Lilly’s Mounjaro (tirzepatide) injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval marks the first new class of drugs for type 2 diabetes in 10 years. Read More
Moderna announced yesterday that it has filed for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in children less than six years old as the FDA comes under intense pressure from many sides to swiftly authorize the vaccine for this population. Read More
The European Medicines Agency’s (EMA) human safety medicines committee signed off on four new drugs during its monthly meeting held from April 19 to 22, including Novartis’ (capmatinib) for treating advanced nonsmall-cell lung cancer. Read More