Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Otsuka’s Jynarque Earns FDA Nod for ADPKD at Second Attempt
Otsuka Pharmaceutical has grabbed US approval for its selective vasopressin V2 receptor antagonist Jynarque (tolvaptan) for the treatment of autosomal dominant polycystic kidney disease (ADPKD) - over four years after the regulator rebuffed the drug, requesting additional data. Otsuka said…
To read the full story
Related Article
- Tolvaptan Re-Submitted to US FDA for ADPKD: Otsuka
November 8, 2017
- US FDA Requests Additional Data for Tolvaptan for Treatment of ADPKD: Otsuka
September 2, 2013
- US FDA Advisory Committee Votes Against Approval of Tolvaptan for Treatment of ADPKD
August 8, 2013
- FDA Accepts Otsuka Tolvaptan NDA for Priority Review
April 17, 2013
BUSINESS
- Takeda Turns the Page to Kim’s “10-Year” Era, Betting on New Drugs and AI
June 26, 2026
- Sangamo Files Chapter 11, Astellas and Lilly Eye Key Assets
June 26, 2026
- Otsuka’s Centanafadine Meets PIII Goal in ADHD Patients with Anxiety
June 26, 2026
- Shionogi Welcomes Government Roadmap’s Focus on Infectious Diseases
June 26, 2026
- Sawai Cleared to Manufacture Nichi-Iko’s Lipitor Generic
June 26, 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…