GSK’s Exdensur wins Japanese nod for severe asthma

The approval follows robust data from the SWIFT and ANCHOR Phase III trials

Chugai’s Tecentriq gets green light in Japan for hard-to-treat Thymic Carcinoma

The drug had previously received orphan drug designation for this rare cancer on March 31, 2025

Bayer wins Japan nod for finerenone in broad heart failure population

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients

Teijin Pharma receives approval for additional indication for XEOMIN in Japan

Sanofi & Regeneron’s Dupixent receives Japanese marketing approval to treat patients with COPD

Dupixent (dupilumab) approved as the first-ever biologic medicine in Japan for patients with Chronic Obstructive Pulmonary Disease (COPD)

Bayer files for approval of finerenone in heart failure in Japan

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure

7th India-Japan medical product regulatory symposium held at New Delhi

Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations

Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer

First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations

Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir

Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.

Astellas submits new drug application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers