Tag Archives: Approves

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 »

FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin

FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin Print this page INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE) December 14, 2018 –Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin®1 (trastuzumab) for the following indications: Adjuvant Breast… Read More »