ARCHIVE

ASCO, FDA Open “Expanded Access”Website on Use of Unapproved Drugs

June 21, 2010
At a press conference held during the 46th annual meeting of the American Society of Clinical Oncology (ASCO 2010), ASCO announced the opening of a new online information site for doctors on unapproved drugs in cooperation with the FDA. This…

To read the full story

ARCHIVE

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Shinya Sato

The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…

By Philip Carrigan

I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…

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…