Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Japan to Ease Olanzapine Diabetes Contraindication for Antiemetic Use
July 31, 2026
- Pipe Damage Causes Water Leak at Sawai Plant after Quake: MHLW
July 30, 2026
- MHLW Urges Stable Supply of Drugs after Kumamoto Earthquake
July 30, 2026
- Kumamoto Quake Hits 46 Medical Facilities; No Pharma Damage Yet: MHLW
July 29, 2026
- Japan Shifts Mo-99 Supply Strategy toward Stronger Global Procurement: Panel
July 29, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
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…