Tag Archives: Approves

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

Home News New Drugs FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin Print this page January 18, 2019 — FDA today approved Ontruzant (trastuzumab-dttb), a biosimilar to U.S.-licensed Herceptin (trastuzumab). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product,… Read More »

FDA Approves Asparlas (calaspargase pegol-mknl) for Acute Lymphoblastic Leukemia (ALL)

Home News New Drugs FDA Approves Asparlas FDA Approves Asparlas (calaspargase pegol-mknl) for Acute Lymphoblastic Leukemia (ALL) Print this page On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (ASPARLAS, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric… 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 »