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 […]
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 […]
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 […]
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 […]
Regeneron Pharmaceuticals and Sanofi have received a significant boost with the European Commission’s (EC) approval of Praluent (alirocumab) for a new indication. The approval enables Praluent to be used as an adjunct treatment to reduce low-density lipoprotein cholesterol (LDL-C) levels in adults with atherosclerotic cardiovascular disease (ASCVD), aiming to lower the risk of further cardiovascular […]
The European Commission (EC) has officially expanded the approval of Takeda Pharmaceutical’s ADCETRIS (brentuximab vedotin) to include the treatment of previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine, and dacarbazine) for adult patients. This new approval is a significant milestone for both Takeda and the Hodgkin lymphoma community, as it […]
In a major win for Clovis Oncology, the European Commission (EC) has granted approval for an expanded indication for its cancer drug, Rubraca (rucaparib). This approval allows the PARP inhibitor to be used as a maintenance treatment for adult women with relapsed ovarian cancer, offering new hope for patients battling this challenging disease. The decision […]
In a landmark deal, Takeda Pharmaceutical Company has successfully completed its previously announced acquisition of Shire, an Irish biotech leader specializing in rare diseases, for a staggering $62 billion. This acquisition marks a major step in Takeda’s ongoing transformation into a global powerhouse in biopharmaceuticals, with an expanded footprint and a deeper focus on rare […]
Novartis has announced that the European Commission has expanded the approval of its multiple sclerosis drug, Gilenya (fingolimod), to include the treatment of children and adolescents aged 10 to 17 years with relapsing-remitting multiple sclerosis. This approval marks Gilenya as the first oral disease-modifying therapy authorized for this younger demographic in Europe. Pioneering oral therapy […]
Mundipharma, a German pharmaceutical company, has achieved a significant milestone with the European Commission (EC)’s approval of Pelmeg, its pegylated biosimilar to Amgen’s Neulasta (pegfilgrastim). Designed to reduce the duration of neutropenia and associated infections in adults undergoing chemotherapy, Pelmeg provides a cost-effective alternative to traditional treatment options. EU Approval of Pelmeg for Neutropenia The […]