The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Data Integrity Risk Detected for Alexion’s Approval-Pending Bleeding Antidote, Report to Panel Put on Hold
Alexion Pharmaceuticals’ andexanet alfa, an antidote for factor Xa inhibitors, was expected to be approved by the end of September, but a data integrity risk that has been detected is now casting clouds on this timeline. Andexanet alfa, known as…
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