Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Orders Label Revisions for Inlyta, Spinraza, and More
The Ministry of Health, Labor and Welfare (MHLW) on January 10 ordered adverse reaction-related label revisions to a batch of drugs including Pfizer’s cancer drug Inlyta (axitinib) and Biogen Japan’s spinal muscular atrophy (SMA) treatment Spinraza (nusinersen). The MHLW urged…
To read the full story
Related Article
- Spinraza under PMDA Risk Review for Hydrocephalus
December 10, 2018
REGULATORY
- Pharma Urges Pricing Rewards to Bolster Japan’s Drug Discovery Strength
September 24, 2026
- Nippon Ishin’s Urano Named Senior Vice Health Minister in Takaichi Cabinet
September 24, 2026
- Ueno Vows to Advance Drug Innovation, Advanced Medicine in 2nd Term
September 24, 2026
- Officer Replacement Orders a “Last Resort” under PMD Act: MHLW Official
September 18, 2026
- Japan Panel Sees No Scientific Objection to Capvaxive NIP Addition
September 18, 2026
Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…