Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Lunsumio Combo Hits PIII Goal in Follicular Lymphoma: Roche
September 18, 2026
- Padcev-Keytruda Gets CHMP Nod for Expanded MIBC Use
September 18, 2026
- SanBio Eyes October Start for Akuugo Treatment
September 18, 2026
- Toho Unit to Launch Pharma-Wholesaler Payment Service
September 18, 2026
- Astellas Names Marino General Counsel, Compliance Chief
September 18, 2026
Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…