Tag Archives: Approves

FDA approves first biosimilar to Roche cancer drug Rituxan

(Reuters) – Celltrion Inc’s Truxima on Wednesday became the first biosimilar to Roche Holding AG’s $ 7-billion-per-year cancer drug Rituxan to be approved in the United States to treat non-Hodgkin’s lymphoma. FILE PHOTO: The logo of Celltrion is seen at company’s headquarters in Incheon, South Korea, October 28, 2016. REUTERS/Kim Hong-Ji The approval by the… Read More »

FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma

Print this page RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon… 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 »