Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Grants Orphan Status to Vyndaqel, Burosumab
The Ministry of Health, Labor and Welfare (MHLW) on May 24 granted orphan designation to Pfizer’s refractory neurological disease treatment Vyndaqel (tafamidis meglumine) and Kyowa Hakko Kirin’s anti-FGF23 monoclonal IgG1 antibody burosumab (KRN23). Vyndaqel earned the orphan status for the…
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REGULATORY
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