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Pegfilgrastim News
Coherus Announces FDA Approval of Udenyca Onbody™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv
Innovative design enables five-minute pegfilgrastim delivery time Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving...
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
FDA Approves Stimufend (pegfilgrastim-fpgk), a Biosimilar to Neulasta
September 6, 2022 – Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced...
FDA Approves Fylnetra (pegfilgrastim-pbbk), a Biosimilar to Neulasta
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- May 27, 2022 – Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has appr...
FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta
NEW YORK--(BUSINESS WIRE)-- June 11, 2020 – Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Nyvepria (pegfilgrastim-apgf), a...
FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta
Holzkirchen, Nov. 5, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo (...
FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta
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...
FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta
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...
FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018 /PRNewswire/ – Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food...
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