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Neupogen News
FDA Approves Nypozi (filgrastim-txid), a Biosimilar to Neupogen
July 01, 2024 Tanvex BioPharma, Inc. (TWSE: 6541) announced that The U.S. Food and Drug Administration (FDA) had completed their review of our submission of Nypozi (TX01) and approved the biologics...
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 Releuko (filgrastim-ayow), a Biosimilar to Neupogen
PISCATAWAY, N.J.--(BUSINESS WIRE)-- March 2, 2022 Kashiv Biosciences, LLC (“Kashiv”) today announced the U.S. Food and Drug Administration (FDA) approval of its Biologics License Application (BLA) for...
FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen
July 20, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen1...
FDA Approves First Biosimilar Product Zarxio (filgrastim-sndz)
March 6, 2015 – The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived...
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