Drug Approval | January 08, 2026
GSK’s Exdensur wins Japanese nod for severe asthma
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
The drug had previously received orphan drug designation for this rare cancer on March 31, 2025
Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients
Dupixent (dupilumab) approved as the first-ever biologic medicine in Japan for patients with Chronic Obstructive Pulmonary Disease (COPD)
Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
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