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CHMP adopts positive opinion for avapritinib for PDGFRA D842V mutant GIST

CHMP adopts positive opinion for avapritinib for PDGFRA D842V mutant GIST

US precision therapy company Blueprint Medicines said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for avapritinib as a monotherapy for certain types of gastrointestinal stromal tumors (GIST). CHMP has recommended conditional marketing authorization of the kinase inhibitor in the European Union for […]

Gilead Sciences announces Veklury EU approval for COVID-19 treatment

Veklury EU approval : Gilead Sciences said that Veklury (remdesivir) has been given conditional marketing authorization from the European Commission as a treatment for SARS-CoV-2 infection, the virus behind COVID-19. According to the US pharma company, the conditional marketing authorization for Veklury was given in the interest of public health because of the coronavirus pandemic […]

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Medivir gets orphan medicinal product designation for MIV-818 for HCC in EU

Swedish biotech company Medivir has secured orphan medicinal product designation from the European Commission for MIV-818 for the treatment of hepatocellular carcinoma (HCC). The orphan medicinal product designation to the pro-drug in the European Union (EU) was granted in accordance with the opinion from the European Medicines Agency (EMA). Although hepatocellular carcinoma is considered to […]

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EC approves Reblozyl for transfusion-dependent anemia in adults

Bristol Myers Squibb and Acceleron Pharma have secured approval from the European Commission (EC) for their jointly developed erythroid maturation agent Reblozyl (luspatercept) for the treatment of transfusion-dependent anemia in adult patients. The approval of Reblozyl is for transfusion-dependent anemia caused by very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had […]

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Takeda gets extended EC approval for ADCETRIS in sALCL

Takeda Pharmaceutical has secured extended approval for ADCETRIS (brentuximab vedotin) in the European Union to include the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) in adult patients. The approval from the European Commission (EC) is for the combination of ADCETRIS with CHP (cyclophosphamide, doxorubicin, prednisone. It comes in the wake of a […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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