Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Turns Down Otsuka’s PTSD Bid for Rexulti
Otsuka Pharmaceutical said on September 22 that it has received a complete response letter from the US FDA, rejecting a label expansion it sought for the antipsychotic Rexulti (brexpiprazole) to treat adult post-traumatic stress disorder (PTSD).The letter, dated September 19,…
To read the full story
Related Article
- FDA Panel Rejects Rexulti’s PTSD Bid: Otsuka/Lundbeck
July 23, 2025
- Rexulti’s PTSD Filing Clinches FDA Acceptance for Review: Otsuka/Lundbeck
June 26, 2024
- Otsuka/Lundbeck Seek PTSD Nod for Rexulti in US
April 10, 2024
- Brexpiprazole Combo Logs Mixed Results in 2 PTSD Trials: Otsuka/Lundbeck
September 8, 2023
BUSINESS
- GNI Targets Above-Industry Growth in Japan after Ayumi Buyout
July 3, 2026
- Sawai Prevails in ALS Drug Contract Appeal against Neugen
July 3, 2026
- Insilico, Takeda Ink AI Drug Discovery Deal Worth Up to US$600 Million
July 3, 2026
- Otsuka’s Voyxact Shows Two-Year Kidney Benefit in PIII IgAN Trial
July 3, 2026
- PeptiDream, NCC Start FIH Study of CLDN18.2 Radiopharmaceutical
July 3, 2026
The number of newly listed generic drugs in Japan has fallen sharply over the past decade, reflecting structural changes in…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…