The Ministry of Health, Labor and Welfare (MHLW) on December 1 granted orphan drug designation for Ono Pharmaceutical’s anti-PD-1 antibody Opdivo (nivolumab) for the treatment of malignant pleural mesothelioma, which affects an estimated 2,000 people in Japan.The MHLW on the…
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REGULATORY
- Japan Grants Sakigake Tag to NS-035, MSA-01
August 26, 2026
- Japan Approves Takeda’s Orzeyful, Insmed’s Brinsupri and More Drugs
August 25, 2026
- Keytruda SC Heads to Japan Approval, Ipsen’s Ojemda for Conditional Nod
August 25, 2026
- Japan Grants Orphan Tags to Rogocekib, Gildeuretinol, and More
August 25, 2026
- Japan Extends Re-Examination Period for Uplizna
August 25, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…





