Tag Archives: European Commission

August, 2017

October, 2016

May, 2016

April, 2016

February, 2016

  • 3 February

    AstraZeneca’s Tagrisso Wins European Approval for Treatment of Lung Cancer

    AstraZeneca today announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Osimertinib is indicated for patients with T790M …

January, 2016

  • 19 January

    Biogen-Samsung’s Enbrel Biosimilar Wins European Approval

    ZUG, Switzerland–(BUSINESS WIRE)–The joint venture between Biogen (NASDAQ:BIIB) and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for BENEPALI® , an etanercept biosimilar referencing Enbrel®i. BENEPALI has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis …

November, 2015

  • 2 November

    EC Approves Celgene’s Vidaza for Treatment of AML

    BOUDRY, Switzerland–(BUSINESS WIRE)– Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that theEuropean Commission (EC) has approved VIDAZA® (azacitidine for injection) for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell …