Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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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