The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Pfizer’s Lorlatinib Gets 1st Conditional OK; MHLW Approves Astellas AML Drug and More
Pfizer’s lung cancer treatment Lorbrena (lorlatinib) earned the world’s first clearance in Japan on September 21, becoming the first drug to gain the nod under the country’s conditional early approval scheme introduced last October. Lorbrena was among a throng of…
To read the full story
Related Article
- Kyorin’s OAB Drug Vibegron and More Clear MHLW Panel; Official Nod Anticipated September
August 31, 2018
- Panel Gives Blessing for Pfizer’s Lorlatinib, Astellas AML Drug; Approval Expected in September
August 30, 2018
- MHLW Panel Backs Lilly’s Ibrance Contender Abemaciclib for Breast Cancer
August 6, 2018
- Daiichi Sankyo's Herceptin Biosimilar Now in Line for September Approval as It Clears MHLW Panel
August 6, 2018
- Boehringer’s DPP-4/SGLT2 Combo Clears MHLW Panel
July 30, 2018
REGULATORY
- Japan to Cut Drug Prices by 0.86% in FY2026; Central Govt Savings Seen at 105 Billion Yen
December 25, 2025
- Japan Growth Strategy Council to Set Up Drug Discovery Working Group
December 25, 2025
- Japan Ministers Agree to Scrap “Spillover” Rule, Plan Wider CEA Price Cuts
December 25, 2025
- Takeda Plans January Rollout of Overseas Plasma-Derived Ig amid Suspension
December 25, 2025
- Japan Panel OKs Label Warning Update for Labor Inducers to Mention Epidural Births
December 25, 2025
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
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…