https://www.statcounter.com/counter/counter.js
Web Analytics
Home » Posts tagged with » European Commission
Sanofi, Regeneron secure Libtayo EMA approval for a type of skin cancer

Sanofi, Regeneron secure Libtayo EMA approval for a type of skin cancer

Libtayo EMA approval : The European Commission has given conditional approval for Libtayo (cemiplimab) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), which is one of the most commonly diagnosed skin cancers. Libtayo, which is a fully-human monoclonal antibody targeting the immune checkpoint receptor programmed cell death […]

ViiV Healthcare secures Dovato EMA approval for HIV-1 treatment

Dovato EMA approval : The European Commission (EC) has approved ViiV Healthcare’s once-daily, single-pill, two-drug regimen Dovato (dolutegravir/lamivudine) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Dovato EMA approval The European approval for Dovato is for adults and adolescents aged over 12 years, weighing more than 40 kg, with no known or […]

Continue reading …
Alexion bags Ultomiris EU approval for paroxysmal nocturnal hemoglobinuria

Ultomiris EU approval : Alexion Pharmaceuticals has secured approval from the European Commission (EC) for its C5 complement inhibitor Ultomiris (ravulizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults. The Ultomiris EU approval is for patients with PNH with hemolysis with clinical symptoms that indicate high disease activity, and also for adult patients […]

Continue reading …
Pixuvri EMA approval : Servier NHL drug secures standard marketing authorization in Europe

Pixuvri EMA approval : French pharma company Servier has secured full approval for Pixuvri (pixantrone) from the European Commission (EC) as monotherapy for aggressive non-Hodgkin B-cell lymphoma (NHL) in adult patients whose condition is multiply relapsed or refractory. Pixuvri EMA approval Since 2012, Pixantrone has been available in Europe to patients following conditional approval, which […]

Continue reading …
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 […]

Continue reading …
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 […]

Continue reading …
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 […]

Continue reading …
Clovis PARP inhibitor Rubraca gets EC approval for relapsed ovarian cancer

Rubraca EC approval : US biotech company Clovis Oncology has secured approval for an additional indication for its cancer drug Rubraca (rucaparib) in Europe – as maintenance treatment for adult women whose ovarian cancer has relapsed. The approval from the European Commission (EC) is for the PARP inhibitor to be used as monotherapy for patients […]

Continue reading …
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 […]

Continue reading …
EC approves Mundipharma’s Neulasta biosimilar Pelmeg for neutropenia

Pelmeg EU approval : The European Commission (EC) has approved German pharma company Mundipharma’s Pelmeg, a pegylated version of granulocyte-colony stimulating factor (G-CSF) and also a biosimilar to Amgen’s neutropenia medication – Neulasta (pegfilgrastim). Pelmeg EU approval for Neutropenia The approval for Pelmeg is for its use as a treatment to bring down the duration […]

Continue reading …
Page 1 of 212