Samsung Bioepis Co, Ltd announced that the US Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. […]
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Vertex Pharmaceuticals Limited announced that the European Commission has granted approval of the label extension for Orkambi (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) aged 2 to 5 years old who have two copies of the F508del mutation, the most common form of the disease. “Today’s approval by the European Commission brings […]
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