The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
BUSINESS
US FDA Accepts sNDA for Fycompa: Eisai
The US FDA has accepted a supplemental new drug application (sNDA) for Eisai’s antiepileptic drug Fycompa (perampanel) for adjunctive treatment of primary generalized tonic-clonic seizures (PGTC) in patients aged 12 and older. Applications for this indication were filed with both…
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BUSINESS
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Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…