Tag Archives: Approves

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 »

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 »

FDA Approves Gamifant (emapalumab-lzsg) for Primary Hemophagocytic Lymphohistiocytosis

FDA Approves Gamifant (emapalumab-lzsg) for Primary Hemophagocytic Lymphohistiocytosis Print this page November 20, 2018 — The U.S. Food and Drug Administration today approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This… Read More »

FDA Approves Daurismo (glasdegib) for Patients with Acute Myeloid Leukemia

FDA Approves Daurismo (glasdegib) for Patients with Acute Myeloid Leukemia Print this page November 21, 2018 — The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75… Read More »

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta Print this page REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients… Read More »