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Results For "European-Commission"

136 News Found

Merck Animal Health receives positive CVMP opinion for an injectable formulation of Bravecto
Drug Approval | December 12, 2023

Merck Animal Health receives positive CVMP opinion for an injectable formulation of Bravecto

The CVMP recommends the product for approval for the treatment and persistent killing of fleas


GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
Drug Approval | November 21, 2023

GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia

Decision on EU marketing authorisation expected for momelotinib by early 2024


Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’
News | November 14, 2023

Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’

Yesafili, received marketing authorization approval from the European Commission for the European Union


Pfizer posts Q3 loss as Covid-19 revenues shrink
News | November 01, 2023

Pfizer posts Q3 loss as Covid-19 revenues shrink

Revenue in the three months ended on Oct. 1 also slipped by 42% to US$ 13.23 billion


Lubrizol launches carbopol polymers for nutraceuticals with new EU good grade approval
News | October 31, 2023

Lubrizol launches carbopol polymers for nutraceuticals with new EU good grade approval

The European Commission approved the use of Carbopol as an additive for liquid and solid food supplements in the EU


Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer
Drug Approval | October 26, 2023

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients


Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer
News | October 25, 2023

Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer

Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada


Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for  cell lung cancer
Drug Approval | September 18, 2023

Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for cell lung cancer

Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial


Pfizer and BioNTech receive positive CHMP opinion for Omicron XBB.1.5-adapted COVID-19 vaccine
News | September 01, 2023

Pfizer and BioNTech receive positive CHMP opinion for Omicron XBB.1.5-adapted COVID-19 vaccine

The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older


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