REGULATORY
MHLW Panel OKs Amgen Astellas’ Romosozumab, but ADHD Drug Vyvanse Put on Hold
A key health ministry panel on December 3 gave the blessing to Amgen Astellas Biopharma’s osteoporosis treatment romosozumab after two years in limbo, while shelving a decision on Shionogi’s ADHD medicine lisdexamfetamine dimesylate, which has been designated as a stimulant.…
To read the full story
Related Article
- MHLW Approves Amgen/Astellas’ Evenity, Gilead Sciences’ Epclusa and More
January 9, 2019
- MHLW OKs Add’l Indications for Keytruda, Tecentriq, Hemlibra, and More
December 25, 2018
- Approvals for Epclusa, Keytruda’s MSI-H Indication and More Could Be Delayed into 2019
December 21, 2018
- MHLW Takes Public Comments on Distribution Management Plan for Shionogi’s ADHD Treatment Vyvanse
December 12, 2018
REGULATORY
- Update: Tavneos Slapped with Blue Letter Action in Japan over Liver Injury Risk
May 22, 2026
- Blister Pack Supplies Seen Returning to Normal: Health Minister
May 22, 2026
- LDP “Eto” Study Group Submits Honebuto Proposal to Health Minister
May 22, 2026
- Oncolys’ Telomelysin Wins Backing from Japan Panel
May 22, 2026
- MHLW Moves Toward Immunization Act Revision for RSV Antibody Drugs
May 21, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





