REGULATORY
Ipsen’s Fidrisertib, Chugai’s Faricimab and 2 More APIs Get Orphan Tags in Japan
The Ministry of Health, Labor and Welfare (MHLW) on March 27 granted orphan drug designation for four APIs including Ipsen’s fidrisertib and Chugai Pharmaceutical’s faricimab.Fidrisertib was designated for the treatment of fibrodysplasia ossificans progressiva, while faricimab earned the status for…
To read the full story
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.…





