The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
US FDA Advisory Committee Votes Against Approval of Tolvaptan for Treatment of ADPKD
Otsuka Pharmaceutical announced on August 6 that the US FDA’s Cardiovascular and Renal Drugs Advisory Committee has recommended against approval of the company’s autosomal dominant polycystic kidney disease (ADPKD) treatment tolvaptan, whose new drug application (NDA) is currently under review.…
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