Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Accepts Astellas/Seagen’s Submissions for Padcev’s Full Approval, Label Expansion
The US FDA has accepted two applications filed by Astellas Pharma and partner Seagen for full approval of their antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) and its label expansion. The target action data was set for August 17, with priority…
To read the full story
Related Article
- Astellas/Seagen’s ADC Padcev Snags Full Approval, Label Expansion
July 13, 2021
- Astellas/Seagen Seek Padcev’s Full Approval, Label Expansion in US
February 22, 2021
- Astellas/Seattle Genetics Nabs FDA OK for 1st-in-Class ADC
December 20, 2019
- Enfortumab Vedotin Gets FDA Priority Review for Urothelial Cancer: Astellas/Seattle Genetics
September 18, 2019
BUSINESS
- Sanofi Delays Japan Launch of Efluelda by One Year, Defers NIP Rollout
July 22, 2026
- Towa Pins NO2 as Key Driver of Nitrosation, Eyes Lower Filter Costs
July 22, 2026
- FRONTEO Taps Bayer Ex-Chair Eiki as Advisor
July 22, 2026
- JCR Grabs 1st Overseas Nod for Izcargo in UAE
July 22, 2026
- Carna Bio’s AML Drug Candidate Earns US Orphan Tag
July 22, 2026
Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…
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 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…