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Novartis defends data on its $2.1 million drug
Novartis is defending its actions in FDA’s review of its $2.1 million drug for a rare pediatric disease.
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GAO: Generic drug approvals too slow
FDA needs to speed up generic drug application reviews, a new report said.
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FDA adds warning to Xeljanz
FDA is adding an important new Boxed Warning to the higher-dose version of the drug.
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