The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Japan Again Takes Pass on Emergency Approval for Shionogi’s COVID Pill as Panels Nix Presumed Efficacy
Panels of Japanese experts on July 20 agreed to put off a decision on whether to grant emergency approval for Shionogi’s oral COVID-19 treatment ensitrelvir, concluding that the drug does not demonstrate “presumed efficacy” with its current data alone. Some…
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