Tag Archives: Approves

FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin

Print this page INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin®i (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma… Read More »

FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)

FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC) Print this page Cambridge, Mass. – December 17, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) has announced that the U.S. Food and Drug Administration (FDA) has approved Motegrity™ (prucalopride), a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation (CIC).1 Motegrity, a… Read More »

FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers

FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers Print this page November 26, 2018 — The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the second time the agency has approved a cancer treatment… Read More »