REGULATORY

MHLW Panel Backs “Sakigake” Influenza Drug; Possibility of Accelerated Approval and Listing Unclear

February 5, 2018
The Second Committee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council, a de-facto decision-making body for marketing approval, recommended approval on February 2 for Shionogi’s influenza type A/B treatment baloxavir marboxil, which has been designated for priority review…

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