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45 News Found

Sanofi & Regeneron’s Dupixent receives Japanese marketing approval to treat patients with COPD
News | March 29, 2025

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)


Bio-Thera & Dr Reddy’s execute commercialization pact for biosimilars Stelara & Simponi for SE Asia
News | March 27, 2025

Bio-Thera & Dr Reddy’s execute commercialization pact for biosimilars Stelara & Simponi for SE Asia

Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and BAT2506


Need for enhancing capacity building of medical officers to achieve desired results of healthcare schemes at the grassroot level: J. P. Nadda
Policy | March 05, 2025

Need for enhancing capacity building of medical officers to achieve desired results of healthcare schemes at the grassroot level: J. P. Nadda

Nadda also commended the role of ASHA workers, “grassroot foot soldiers”, in the healthcare system


Bayer files for approval of finerenone in heart failure in Japan
News | February 15, 2025

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
News | August 19, 2024

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
Drug Approval | August 03, 2024

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
Policy | July 14, 2024

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
Drug Approval | March 30, 2024

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
News | January 08, 2024

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
Drug Approval | August 25, 2023

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