Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Accepts NDA Resubmission for Sunovion’s COPD Med
The US FDA has accepted the resubmission of a new drug application for Sunovion Pharmaceuticals’ chronic obstructive pulmonary disease (COPD) treatment SUN-101/eFlow (glycopyrrolate), with a target action date under the Prescription Drug User Fee Act (PDUFA) set for December 15.…
To read the full story
Related Article
- Nebulized COPD Med Lonhala Magnair Now Available in US: Sunovion
April 5, 2018
- FDA Clears Sunovion’s Nebulized COPD Drug
December 7, 2017
- Sunovion’s COPD Med Slapped with FDA Complete Response Letter
May 30, 2017
- PDUFA Date for COPD Drug Set for May 29, 2017: Sunovion
October 17, 2016
- Sunovion Submits US NDA for COPD Drug
August 2, 2016
BUSINESS
- Chugai Forms Strategic Investment Unit to Deepen Innovation Push; Record Japan Filings Eyed
July 27, 2026
- Chugai Notches Strong H1 Growth on Key Products, Roche Exports
July 27, 2026
- Meiji’s Hiyasta Hits PIII Goal in Advanced Melanoma
July 27, 2026
- China First to Approve Takeda’s Oveporexton for Narcolepsy
July 24, 2026
- FRONTEO Expects First US User of KIBIT AI Engine This Year: CEO
July 24, 2026
Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…
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…