REGULATORY
Japan OKs Bayer’s MRI Agent, Haihe’s PI3Kα Med, Enhertu’s Tumor-Agnostic Use, and More
Japan granted regulatory approvals for a throng of new medicines and label expansions on March 23, including Bayer’s low-dose MRI contrast agent Ambelvist (gadoquatrane) and Haihe Biopharma’s PI3Kα inhibitor Haizexin (risovalisib). The Ministry of Health, Labor and Welfare (MHLW) gave…
To read the full story
Related Article
- Japan to List 1st Biosimilars for Xolair, Ranmark, Simponi on May 20
May 19, 2026
- Japan OKs Listing of Ambelvist, Dojolvi, Sohonos, and Finally Inrebic
May 14, 2026
- Celltrion Wins First Xolair Biosimilar Approval in Japan, Targets May Listing
March 24, 2026
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
REGULATORY
- Japan, US Launch Talks on Pharma GMP MRA to Ease Inspection Burden
July 3, 2026
- MHLW Gives Kissei until July 21 to Report on Tavneos
July 3, 2026
- Centrist Reform Alliance Warns US MFN Policy Poses “Real Crisis” for Drug Access
July 3, 2026
- Ishin Urges Govt to Make Healthcare, Drug Innovation Core Growth Strategy
July 3, 2026
- MHLW Seeks Sponsors for 6 High-Need Unapproved, Off-Label Drugs
July 2, 2026
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…





