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Ziextenzo 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 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 (...
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