Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
US FDA Requests Additional Data for Tolvaptan for Treatment of ADPKD: Otsuka
Otsuka Pharmaceutical announced on August 30 that it has received a Complete Response Letter (CRL) from the US FDA, stating that the agency cannot approve the company’s vasopressin V2 receptor antagonist tolvaptan for the treatment of adult patients with rapidly…
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
BUSINESS
- Roche Proposes Ex-Takeda CEO Weber for Board
September 24, 2026
- Moderna Launches XFG-Updated mNEXSPIKE in Japan
September 24, 2026
- FDA Accepts Tanabe’s EPP/XLP Drug for Priority Review
September 24, 2026
- GenAI Use at Japan Pharmas Rises to 92% in 2026: Funlead Survey
September 24, 2026
- Japan OKs FoundationOne CDx for Pfizer’s Lorbrena
September 24, 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…