Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Rexulti’s PTSD Filing Clinches FDA Acceptance for Review: Otsuka/Lundbeck
Otsuka Pharmaceutical and Lundbeck said on June 25 that the US FDA has accepted for review an application seeking the label expansion of their antipsychotic Rexulti (brexpiprazole) to treat post-traumatic stress disorder (PTSD). The submission seeks the nod for Rexulti’s…
To read the full story
Related Article
- FDA Turns Down Otsuka’s PTSD Bid for Rexulti
September 24, 2025
- FDA Panel Rejects Rexulti’s PTSD Bid: Otsuka/Lundbeck
July 23, 2025
- 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
- Incyte Looks to More Than Double International Business by 2030: CEO
March 18, 2026
- Stella Pharma Files Steboronine for Recurrent Meningioma
March 18, 2026
- SymBio Enrolls First Patient in US for PIII BCV Trial in Adenovirus Infection
March 18, 2026
- Oral Flu Drugs Prescribed to 2.46 Million in February as Cases Surge Again: Intage
March 17, 2026
- ADDP, Proteros Tie Up to Expand Drug Discovery Support
March 17, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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,…
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…