Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Novartis’ Radioligand Therapy, More Meds Inch Closer to Japan Approval with Panel OK
A Japanese health ministry panel on August 22 recommended regulatory approval for Novartis’ radioligand therapy lutetium vipivotide tetraxetan (177Lu) along with a batch of other new medicines and indications. First biosimilars for three compounds are also in line for approval.…
To read the full story
Related Article
- J&J Files for 4-Week SC Dosing of Rybrevant in Japan
October 28, 2025
- Japan Hands Out Orphan Tags to 10 Compounds
September 30, 2025
- Japan Approves Pluvicto, Izervay, and Lots More; Subcutaneous Rybrevant Not on Roster
September 22, 2025
- J&J’s Subcutaneous Rybrevant Faces Delay in Japan Approval Process
September 17, 2025
- Novartis’ Radioligand Therapy, Other New Meds Up for Japan Panel Review on Aug. 22
August 12, 2025
- Japan Nears Approval for 1st Biosimilars of Actemra, Simponi, and Ranmark
August 12, 2025
- Nippon Kayaku Files Nuvation-Partnered ROS1 Inhibitor in Japan
March 5, 2025
- Boehringer Files Zongertinib in Japan for HER2 Lung Cancer
February 19, 2025
- Nihon Servier Files Glioma Drug Vorasidenib in Japan
December 25, 2024
- Alfresa Files ARS’ Epinephrine Nasal Spray in Japan
December 2, 2024
- Vectibix Plus Lumakras Filed for Colorectal Cancer in Japan
November 11, 2024
- Tecentriq Filed for Rare Nasal Lymphoma in Japan: Chugai
November 1, 2024
REGULATORY
- 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
- 3 Label Expansions Get NHI Coverage on Public Knowledge Pathway
July 29, 2026
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
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…