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Results For "European-Union"

229 News Found

European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ
Drug Approval | August 30, 2023

European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ

KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population


USFDA approves Merck’s ERVEBO for use in children 12 months of age and older
Drug Approval | August 05, 2023

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease


Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin
News | July 22, 2023

Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin

Good momentum in commercial CDMO business


Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction
Drug Approval | July 22, 2023

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU


Novavax's Nuvaxovid receives full marketing authorization in the EU
News | July 10, 2023

Novavax's Nuvaxovid receives full marketing authorization in the EU

Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU


Moderna announces regulatory submissions for its RSV vaccine
News | July 10, 2023

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia


Lonza signs VPPA for solar power supply with Ignis
News | June 09, 2023

Lonza signs VPPA for solar power supply with Ignis

Under the terms of the VPPA, IGNIS will produce renewable energy equal to Lonza’s electricity needs across Switzerland and the European Union.


Venus Remedies receives Ukrainian GMP approval for Its Carbapenem, Oncology parenteral facilities
News | June 08, 2023

Venus Remedies receives Ukrainian GMP approval for Its Carbapenem, Oncology parenteral facilities

The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations