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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 […]

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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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Pfizer lung cancer drug Vizimpro bags CHMP’s positive opinion

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Pfizer lung cancer drug Vizimpro (dacomitinib) 45 mg in Europe as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The positive opinion adopted by the European Medicines Agency (EMA) committee is […]

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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 […]

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Spark Therapeutics bags Luxturna EU approval for inherited retinal disease

Luxturna EU approval for inherited retinal disease : Pennsylvania-based Spark Therapeutics has bagged the European Commission’s (EC) approval for its gene therapy Luxturna (voretigene neparvovec) to treat a rare inherited type of vision loss in both children and adults. Luxturna EU approval for inherited retinal disease Luxturna, an adeno-associated viral (AAV) vector gene therapy has […]

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Mylan launches Humira biosimilar Hulio across Europe

Mylan has launched Hulio, a biosimilar to AbbVie’s Humira (adalimumab), in major markets in Europe, a month after its approval from the European Commission for all indications of the reference product. Hulio will be available to patients as early as possible, said Mylan, which partnered with Fujifilm Kyowa Kirin Biologics in April to commercialize the […]

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