Sakigake Status Granted to Takeda’s Narcolepsy Med, Ninlaro, Daiichi Sankyo’s Valemetostat and More
To read the full story
Related Article
- Rakuten Medical’s Photoimmunotherapy Filed in Japan, Subject to Conditional Early OK
July 1, 2020
- Rakuten Medical Could File Photoimmunotherapy for Head and Neck Cancer in 2022; COO Says More Indications Eyed
June 12, 2019
- Takeda Calls Off PIII Study of Sakigake-Designated Ninlaro for AL Amyloidosis after Failing to Hit Primary Goal
June 7, 2019
- Sakigake Status Goes to World’s 1st Renal-Function Improving Agent, BBB-Penetrating Hunter Syndrome Med and 4 More Drugs
March 28, 2018
- Sakigake Fast-Track Designation Given to Aducanumab, 4 Other Products
April 24, 2017
- 6 Drugs Get Sakigake Designation for Fast-Track Review
October 27, 2015
REGULATORY
- Japan Panel Again Defers Male HPV Shots amid Cost-Effectiveness Concerns
October 9, 2026
- Takaichi Defends Off-Year Drug Price Revisions as DPP Calls for Abolition
October 9, 2026
- Japan Orders Contraindication for Adlumiz-Noxafil Combination
October 9, 2026
- Imcivree, Hibsago Get Chuikyo Nod for Home Self-Injection
October 9, 2026
- Provider-Payer Tug-of-War Takes Shape over FY2027 Drug Price Revision
October 8, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…





