Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Turns Down Label Update for Izervay, Astellas Eyes Re-Filing
Astellas Pharma said on November 19 that the US FDA has declined to approve a label update that the company sought for its complement C5 inhibitor Izervay (avacincaptad pegol) to include favorable two-year clinical trial data. The drug scored the…
To read the full story
Related Article
- FDA Approves Izervay’s Wider Label with No Dosing Duration Limit
February 14, 2025
- FDA Accepts Re-Submission of Izervay to Buttress Label
January 10, 2025
- Astellas Pulls EU Filing for Geographic Atrophy Drug
October 29, 2024
- Izervay Slows Geographic Atrophy Lesion Growth through 2 Years: Astellas
November 7, 2023
- Iveric Bio’s AMD Drug Approved in US, Launch Set for This Month: Astellas
August 8, 2023
BUSINESS
- Kissei Discussing Japan Response after EU Panel Recommends Pulling Tavneos Approval
June 29, 2026
- Sanofi Files Venglustat for Gaucher Disease in Japan
June 29, 2026
- Santen’s Myopia Drug Ryjusea Wins Nod in Philippines
June 29, 2026
- Toho Shareholders Approve Trigger for 3D Defense Measures
June 29, 2026
- Nippon Shinyaku Bags Option on Elixirgen’s DMD Candidate
June 29, 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…