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A group of senators hit out at Novartis subsidiary AveXis on Friday for using falsified data in the approval process of its gene therapy product Zolgensma (onasemnogene abeparvovec-xioi). Read More
The agency will not award any vouchers after Sept. 30, 2020, unless the application is for a drug that was designated as a drug for a rare pediatric disease. Read More
The FDA has okayed the use of a single trial to prove efficacy of any drug developed to treat Fabry Disease, according to a draft guidance the agency issued last week. Read More