The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
BUSINESS
FDA Panel Rejects Rexulti’s PTSD Bid: Otsuka/Lundbeck
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
- FDA Turns Down Otsuka’s PTSD Bid for Rexulti
September 24, 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
- Envudeucitinib Hits PIII Goals in Psoriasis, JNDA Planned for 2027: Kaken
January 8, 2026
- Pharma Leaders Press for Drug Pricing Overhaul at New Year’s Confab
January 8, 2026
- Generic Entry into DPP-4 Class Poised to Accelerate in 2026
January 7, 2026
- Takeda Files Polycythemia Vera Drug Rusfertide in US
January 7, 2026
- Daito Snags China Approval for Iguratimod, Its Third Product
January 7, 2026
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
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…