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According to the website of the CDE on June 10, the marketing applications of Roche for its new drug Baloxavir Marboxil Tablets in China have been accepted by the CDE.
Roche has unveiled late-stage data showing that its experimental antivrial drug baloxavir marboxil hit efficacy and safety targets in patients with flu.
Genentech announced the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose