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

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

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

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

Mandaviya inaugurates CDSCO Sub Zonal Office and Central Drug Testing Laboratory in Indore

Lays Foundation Stone of 6 new facilities at AIIMS Bhopal and inaugurates a slew of facilities in Madhya Pradesh

Lynparza plus abi/pred approved in Japan for treatment of prostate cancer

First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent

PNB Housing and PVRI launch Pehel Eye Mitra to deliver free transport services to eye patients

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