Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Kyowa Kirin’s Burosumab Earns Conditional Approval in Europe
Kyowa Hakko Kirin’s anti-FGF23 monoclonal IgG1 antibody burosumab (KRN23) has grabbed conditional approval in Europe for the treatment of X-linked hypophosphatemia (XLH) in children, which marks the world’s first green light for the drug globally, the company and its US…
To read the full story
Related Article
- Crysvita Approved in Europe for Adult XLH: Kyowa Kirin
October 6, 2020
- EU Panel Backs Kyowa Kirin’s Crysvita for Adult XLH
July 28, 2020
- Crysvita Accepted for Review in Europe for Additional Adult Use
November 6, 2019
- Kyowa Kirin’s Burosumab Gains European Panel Backing for Conditional Approval
December 19, 2017
- Kyowa Kirin’s KRN23 Filed in Europe for X-Linked Hypophosphatemia
January 6, 2017
BUSINESS
- Ultragenyx Seeks Japan Approval for GSDIa Gene Therapy
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
- Viatris Eyes Japan Filing This Year for IgAN Drug
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…