REGULATORY
Yescarta Sails through PAFSC Review; Panel Roughly OKs Novartis’ Corrective Measures after Zolgensma Delay
A key health ministry advisory panel recommended approval for Japan’s second CAR-T cell therapy axicabtagene ciloleucel, known as Yescarta, on December 3, while roughly endorsing corrective measures proposed by Novartis Pharma after the company’s botched the handling of its SMA…
To read the full story
Related Article
- Second CAR-T Therapy Yescarta Up for Panel Review; MHLW to Report Corrective Measures for Zolgensma Issue
November 27, 2020
- Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
September 8, 2020
- Will Zolgensma Delay Spur Revision of Sakigake Designation System?
June 11, 2020
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
April 8, 2020
- Daiichi Sankyo Files Yescarta, Second CAR-T Therapy in Japan
March 30, 2020
REGULATORY
- Japan Panel to Review Pfizer’s Cancer Med Tukysa on January 29
January 16, 2026
- Study Group Calls for Independent Body to Centrally Manage Whole Genome Data
January 16, 2026
- Expert Calls for Full Verification of CEA Guidelines and Analytical Frameworks
January 16, 2026
- Japan Sets New Pricing Rules for Conditionally Approved Regenerative Medicines, Starting with Elevidys
January 15, 2026
- MHLW Orders Label Revisions for Aspirin, CAR-T Therapies, and Other Drugs
January 14, 2026
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…





