Quick Look: An MHLW panel recommended approval for two NMEs on April 27: Boehringer’s nerandomilast and Moderna’s mRNA COVID-19 vaccine. The session also backed label expansions for Sotyktu, Fasenra, and Alecensa, while the ministry reported plans to broaden indications for…
To read the full story
Related Article
- Japan Panel to Review Boehringer’s IPF Drug, Moderna COVID Shot on April 27
April 21, 2026
- MHLW Council Clears Public Knowledge Filing for MabCampath in T-PLL
October 1, 2025
- Chugai Files Alecensa for ALK-Positive Solid Tumors in Japan
June 27, 2025
- GSK’s RSV Vaccine Arexvy Filed for High-Risk Adults Aged 18-49 in Japan
June 23, 2025
- Moderna Files Next-Gen COVID Vaccine in Japan
June 23, 2025
- Boehringer Files Nerandomilast for Pulmonary Fibrosis in Japan
June 13, 2025
- BMS Files Label Expansion of Sotyktu for Psoriatic Arthritis in Japan
June 9, 2025
REGULATORY
- AstraZeneca’s Oral SERD, MSD RSV Antibody Up for Japan Panel Review on May 25
May 12, 2026
- Daiichi Sankyo Wins Japan Approval for MMR Vaccine Mimrit
May 12, 2026
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 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…





