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The FDA has accepted for review the first two novel, personalized cancer treatments — known as chimeric antigen receptor T-cell therapies, or CAR-T — using immune system cells drawn from the blood and reprogrammed to target cancer cells. Read More
The FDA issued a complete response letter Wednesday to Mylan for its generic version of the Advair Diskus asthma inhaler developed by GlaxoSmithKline. Read More
An FDA advisory committee unanimously voted to recommend approval of Genentech’s new subcutaneous formulation of Rituxan for several blood cancer indications. Read More