Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Accepts Eisai’s Fycompa for Pediatric Indication Review
Eisai said on May 31 that the US FDA has accepted its supplemental new drug application (sNDA) for its anti-epilepsy agent Fycompa (perampanel) seeking to expand its label to include pediatric patients with epilepsy. The drug was put on a…
To read the full story
Related Article
- FDA OKs Pediatric Label Expansion for Fycompa: Eisai
October 2, 2018
- Fycompa Filed for Label Expansion in US for Pediatric Epilepsy
April 3, 2018
- Fycompa Approved for Monotherapy for Partial Epilepsy in US
July 28, 2017
BUSINESS
- Ultragenyx Seeks Japan Approval for GSDIa Gene Therapy
July 1, 2026
- Specialist Hails Wegovy as “Game Changer” for MASH Treatment
July 1, 2026
- Alfresa Boosts Stake in ENT Cell Sheet Startup
July 1, 2026
- Eisai, UCL Renew Neuroscience Alliance to 2030
July 1, 2026
- Asahi Kasei Nabs Japan Rights to Additional Empaveli Indications
July 1, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
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…