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Fulphila News
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 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 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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