Applications for approval using electronic data in conformity with CDISC standards, which have been accepted since October last year, were filed for 19 products as of March 17, an official of the Pharmaceuticals and Medical Devices Agency (PMDA) announced on…
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REGULATORY
- 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
- 4 Drug Makers Seek Govt Aid to Upgrade Aging Plants: LDP Hearing
August 24, 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.…





