Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Xtandi Gets FDA Priority Review Status for Add’l CRPC Indication
Pfizer and Astellas Pharma said on March 19 that the US FDA has accepted a supplemental new drug application for Xtandi (enzalutamide) and granted priority review designation for the treatment of non-metastatic castration-resistant prostate cancer (CRPC). The Prescription Drug User…
To read the full story
Related Article
- FDA OKs Xtandi for Non-Metastatic Prostate Cancer
July 18, 2018
BUSINESS
- Enhertu Earns EMA Panel OK for HER2 Positive Solid Tumors
May 25, 2026
- Datroway Snares US Approval in 1st-Line TNBC: Daiichi Sankyo
May 25, 2026
- Net Profit at 24 Japan Drug Makers Tops 2 Trillion Yen, Led by Astellas and Sumitomo
May 25, 2026
- Padcev-Keytruda Gets CHMP Nod for Cisplatin-Ineligible Bladder Cancer
May 25, 2026
- Japan Market Hits Record 11.8 Trillion Yen in FY2025, Keytruda Keeps Title: IQVIA
May 22, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…