Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
US FDA Advisory Committee Votes Against Approval of Tolvaptan for Treatment of ADPKD
Otsuka Pharmaceutical announced on August 6 that the US FDA’s Cardiovascular and Renal Drugs Advisory Committee has recommended against approval of the company’s autosomal dominant polycystic kidney disease (ADPKD) treatment tolvaptan, whose new drug application (NDA) is currently under review.…
To read the full story
Related Article
- Otsuka’s Jynarque Earns FDA Nod for ADPKD at Second Attempt
April 26, 2018
- Tolvaptan Re-Submitted to US FDA for ADPKD: Otsuka
November 8, 2017
REGULATORY
- Government Unveils Four-Chapter Outline for 2026 Honebuto
June 26, 2026
- LDP, Ishin Leave Chuikyo Reform to Party Negotiators after Talks Stall
June 26, 2026
- Japan Targets Global-Level Growth for Domestic Patented Drug Market
June 25, 2026
- Paxlovid, Awiqli Braced for NHI Price Cuts after CEAs
June 25, 2026
- Drug Pricing to Be Applied to Oncolys Oncolytic Virus Therapy
June 25, 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…