Second CAR-T Therapy Yescarta Up for Panel Review; MHLW to Report Corrective Measures for Zolgensma Issue
To read the full story
Related Article
- Yescarta Sails through PAFSC Review; Panel Roughly OKs Novartis’ Corrective Measures after Zolgensma Delay
December 4, 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
- MHLW Calls for Ongoing Nitrosamine Risk Controls after Self-Inspections
July 24, 2025
- 223 Health Damages Reported for Breyanzi in Japan: October-March
July 24, 2025
- MHLW Plans to Ease Clinical Trial Ad Rules, Eyes Notification by March-End
July 24, 2025
- New MHLW Drug Review Chief Aims to Dispel “Barrier” Perception, Pledges Active Engagement with Industry
July 23, 2025
- Healthcare Stakeholders Weigh Fallout after Ruling Bloc’s Election Setback
July 23, 2025
I recently attended a fantastic conference hosted by Prospection Japan, and one speaker, Dr. Joe Ledsam, really blew me away with his insights. He shared some truly fascinating developments about how AI is set to revolutionize healthcare, from how doctors…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…