The Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing the risk of hydrocephalus for Biogen Japan’s spinal muscular atrophy (SMA) treatment Spinraza (nusinersen) - a move that is likely to result in label changes - according to the agency’s risk…
To read the full story
Related Article
- MHLW Orders Label Revisions for Inlyta, Spinraza, and More
January 11, 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.…





