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Results For "Drugs-Controller-General-of-India"

87 News Found

AstraZeneca Pharma India to launch Enhertu in January 2024
News | December 20, 2023

AstraZeneca Pharma India to launch Enhertu in January 2024

Trastuzumab deruxtecan (Enhertu) is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer


Aurobindo to launch HIV triple combination product for children living with HIV in low and middle-income countries
News | August 17, 2023

Aurobindo to launch HIV triple combination product for children living with HIV in low and middle-income countries

Aurobindo's product is already filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon


AstraZeneca India receives permission from DCGI for Dapagliflozin
Drug Approval | July 25, 2023

AstraZeneca India receives permission from DCGI for Dapagliflozin

The approval allows treatment of heart failure patients irrespective of the ejection fraction based on new trial DELIVER conducted by AstraZeneca


DGCI grants Emergency Use Authorisation to Gennova mRNA Covid booster vaccine
News | June 21, 2023

DGCI grants Emergency Use Authorisation to Gennova mRNA Covid booster vaccine

The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield


Govt. appoints Rajeev Raghuvanshi new DGCI
People | February 24, 2023

Govt. appoints Rajeev Raghuvanshi new DGCI


Hetero's COVID-19 oral drug gets WHO prequalification
News | December 27, 2022

Hetero's COVID-19 oral drug gets WHO prequalification

WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate COVID-19 patients at highest risk of hospital admission


Biocon initiates clinical study of Itolizumab for ulcerative colitis in India
Clinical Trials | December 15, 2022

Biocon initiates clinical study of Itolizumab for ulcerative colitis in India

This is a phase two randomized, double-blind, parallel-group, placebo and active-controlled study


DCGI approves AstraZeneca 's Olaparib film-coated tablets
Drug Approval | August 20, 2022

DCGI approves AstraZeneca 's Olaparib film-coated tablets

Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer