Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Padcev/Keytruda Combo Nabs FDA Nod for 1st Line Bladder Cancer
Astellas Pharma said on December 15 that the US FDA has granted approval for a combination of its antibody drug conjugate Padcev (enfortumab vedotin) and Merck’s PD-1 inhibitor Keytruda (pembrolizumab) for the frontline treatment of locally advanced or metastatic urothelial…
To read the full story
Related Article
- Padcev-Keytruda Approved in Europe for 1st Line Bladder Cancer
August 29, 2024
- Padcev-Keytruda Nears EU Nod for 1st Line Bladder Cancer
July 30, 2024
- Padcev/Keytruda Accepted for Chinese Review for 1st Line Bladder Cancer Use
March 29, 2024
- Japan Awards Priority Review for Keytruda/Padcev in Bladder Cancer: Astellas
February 19, 2024
- Keytruda/Padcev Filed in Japan for 1st Line Bladder Cancer Treatment: MSD, Astellas
February 1, 2024
- Astellas/Pfizer Seeks 1st Line Bladder Cancer Use for Padcev/Keytruda in EU
January 30, 2024
- Padcev/Keytruda Combo Gets FDA Priority Review for Bladder Cancer
December 4, 2023
- Padcev/Keytruda Combo Wins US Accelerated Nod for First-Line Bladder Cancer: Astellas
April 5, 2023
BUSINESS
- Halaven Generics Obtain Soft Tissue Sarcoma Use
September 3, 2026
- Ono Teams with Aitia in AI-Driven Neurology Drug Discovery
September 3, 2026
- Nippon Kayaku’s Generic Sunitinib Gains Pancreatic NET Use
September 3, 2026
- GSK Hit with MHLW Guidance over Sponsored Lecture
September 2, 2026
- Nonprescription Cialis Goes Nationwide in Japan, Now at 10,000 Outlets
September 2, 2026
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…
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
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…