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Nyvepria 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 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...

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