Tag Archives: Approves

FDA Approves Cablivi (caplacizumab-yhdp) for Acquired Thrombotic Thrombocytopenic Purpura (aTTP) in Adults

FDA Approves Cablivi (caplacizumab-yhdp) for Acquired Thrombotic Thrombocytopenic Purpura (aTTP) in Adults Print this page February 6, 2019 — The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP),… Read More »

FDA Approves Osphena (ospemifene) for Moderate to Severe Vaginal Dryness Due to Menopause

Print this page BLAINVILLE, QC, January 29, 2019 – Duchesnay Inc., a pharmaceutical company specializing in women’s health, announced today that the FDA has approved its supplemental New Drug Application (sNDA) seeking to add moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA), due to menopause, to the indication of Osphena… Read More »

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 Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) December 19, 2018 –Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based… Read More »

FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery

FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery Print this page BEDFORD, Mass.–(BUSINESS WIRE)–Dec. 3, 2018– Ocular Therapeutix™, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Food and Drug Administration… Read More »