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Results For "European-Commission"

123 News Found

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


Merck receives positive European Union CHMP opinion for Gefapixant
News | July 22, 2023

Merck receives positive European Union CHMP opinion for Gefapixant

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union


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