BUSINESS

Taiho Begins Rolling US NDA Submission for Zipalertinib

November 26, 2025
Taiho Pharmaceutical and development partner Cullinan Therapeutics said on November 21 that they have begun a rolling submission of a new drug application to the US FDA for zipalertinib, an EGFR tyrosine kinase inhibitor. The planned filing seeks approval for…

To read the full story

Related Article

BUSINESS

Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

By Philip Carrigan

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…

By Shinya Sato

More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

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…