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Results For "European-Medicines-Agency"

210 News Found

Alkem to launch novel antibiotic for MDR infections
News | January 31, 2023

Alkem to launch novel antibiotic for MDR infections

Zidavi is recommended by the Infectious Disease Society of America


Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr
News | January 24, 2023

Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr

The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid


InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong
Drug Approval | December 31, 2022

InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency


Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers
Drug Approval | December 20, 2022

Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers

Positive opinions based on significant survival benefit


Takeda’s dengue vaccine QDENGA approved for use in EU
Drug Approval | December 09, 2022

Takeda’s dengue vaccine QDENGA approved for use in EU

The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022


Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate
News | December 05, 2022

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


WuXi STA launches parenteral formulation manufacturing line at Wuxi
News | December 01, 2022

WuXi STA launches parenteral formulation manufacturing line at Wuxi

This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units