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49 News Found

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


Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir
News | June 27, 2023

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
News | June 13, 2023

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


Ezharima launched in Japan as first dual EZH1 and EZH2 inhibitor therapy for leukemiaLymphoma
News | December 20, 2022

Ezharima launched in Japan as first dual EZH1 and EZH2 inhibitor therapy for leukemiaLymphoma

EZHARMIA is the fifth innovative oncology medicine to be launched in Japan by Daiichi Sankyo in the past three years


Mandaviya inaugurates ICMR-NARFBR in Hyderabad
News | December 19, 2022

Mandaviya inaugurates ICMR-NARFBR in Hyderabad

The newly built centre will work as the state-of-the-art facility for not just ethical animal studies but spans from basic, applied to regulatory animal research.


Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer
Drug Approval | November 27, 2022

Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer

Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial