BUSINESS

FDA Accepts NDA Resubmission for Sunovion’s COPD Med

July 4, 2017
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

BUSINESS

Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

By Shinya Sato

Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…

By Philip Carrigan

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,…

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…