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
- Keytruda Holds Top Spot for 35th Straight Month in August: Encise
September 7, 2026
- Fuji Curbs Shipments of Simponi, Ranmark Biosimilars Soon after Launch
September 4, 2026
- Leqembi Subcutaneous Autoinjector Approved in China
September 4, 2026
- Nxera Gets US$8.6 Million OX2R Milestone from Centessa
September 4, 2026
- Top Medipal Shareholder Seeks CEO Ouster, Special Dividend
September 4, 2026
Japan has entered a third straight year of wage hikes averaging 5%, but the pharmaceutical industry is struggling to keep…
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…