BUSINESS

FDA Panel Rejects Rexulti’s PTSD Bid: Otsuka/Lundbeck

July 23, 2025
US FDA advisors have issued a negative recommendation for an additional indication of Otsuka Pharmaceutical/Lundbeck’s antipsychotic Rexulti (brexpiprazole) for the treatment of post-traumatic stress disorder (PTSD) in adults. The partners said on July 19 that the FDA’s Psychopharmacologic Drugs Advisory…

To read the full story

Related Article

BUSINESS

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

Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…

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…