REGULATORY
Label Revisions Ordered for PD-1 Inhibitors, Ibrance, Maviret, and More
The Ministry of Health, Labor and Welfare (MHLW) on February 12 ordered label revisions related to adverse reactions for a batch of drugs including major PD-1 inhibitors Opdivo (nivolumab) and Keytruda (pembrolizumab), AbbVie’s hepatitis C drug Maviret (glecaprevir + pibrentasvir),…
To read the full story
Related Article
- Maviret, Ibrance, PD-1 Inhibitors under PMDA Risk Review
January 21, 2019
REGULATORY
- MHLW Lifts Olanzapine Diabetes Contraindication for Antiemetic Use
August 26, 2026
- PMDA Flags Severe Gastritis, Esophagitis with Checkpoint Inhibitors
August 26, 2026
- 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
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.…





