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Pharma giants bag Lynparza EMA approval for metastatic breast cancer

Pharma giants bag Lynparza EMA approval for metastatic breast cancer

Lynparza EMA approval : Pharma giants AstraZeneca and MSD have secured an expansion of the European Medical Agency’s (EMA) approval for their poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) to be used for the treatment of a type of advanced breast cancer. The expanded Lynparza EMA approval allows the PARP inhibitor to be used as […]

Praluent bags EC approval to reduce risk of CV events in patients with ASCD

Regeneron Pharmaceuticals and Sanofi have secured approval for Praluent (alirocumab) for a new indication from the European Commission (EC), which is for the reduction of cardiovascular risk in adults with established atherosclerotic CV disease (ASCD) by reducing low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correct other risk factors. Atherosclerotic CV Disease is defined […]

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Takeda bags ADCETRIS EC approval for CD30+ Stage IV Hodgkin lymphoma

ADCETRIS EC approval : The European Commission (EC) has expanded the approval of Takeda Pharmaceutical’s ADCETRIS (brentuximab vedotin) to cover treatment of previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine) in adult patients. ADCETRIS is an antibody-drug conjugate (ADC) that targets CD30, which is a defining marker of […]

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Novartis bags Gilenya EC approval for multiple sclerosis in young patients

Gilenya EC approval : The European Commission (EC) has expanded the approval of Novartis multiple sclerosis drug Gilenya (fingolimod) to include the treatment of both children and adolescents, in the age group 10-17 years. Expanded Gilenya EC approval The expanded Gilenya EC approval is for the treatment of relapsing-remitting forms of multiple sclerosis (RRMS). Novartis already […]

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Novartis skin cancer drug combo bags EC approval for type of melanoma

Novartis has secured approval from the European Commission (EC) for its skin cancer drug combo Tafinlar (dabrafenib) and Mekinist (trametinib) as an adjuvant therapy for stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection. The latest approval marks the third for the Tafinlar-Mekinist combination in Europe for various tumor types identified with […]

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Janssen bags EC approval for daratumumab for multiple myeloma

Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing authorization for its monoclonal antibody Darzalex (daratumumab) from the European Commission (EC) as initial therapy for adult patients with newly diagnosed multiple myeloma, who are not eligible for autologous stem cell transplant (ASCT). The EC approval is for the use of daratumumab in combination with […]

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