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LinkedIn Articles

FDA INTERNATIONAL INSPECTION APPROACH- PART II

FDA INTERNATIONAL INSPECTION APPROACH- PART 1

Don’t Buy New Cell Line or RCB !! Save Millions by Doing This Instead…

Why 10 Lots are Important

Cliff Notes for New Interchangeability Draft Guidance by FDA

FDA Friend or FOE for Biosimilar Companies

RSS Big Molecule Watch

  • Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program May 15, 2025 Amy Tso|Alexandra Lu
  • President Trump Issues Two Executive Orders Concerning the Affordability and Accessibility of Drugs May 15, 2025 Timothy Beavers|Matt Wetzel|Natasha Daughtrey|Kevin DeJong|Elizabeth Mulkey
  • EMA Issues Positive CHMP Opinions for Biocon’s Denosumab Biosimilars May 9, 2025 Alison Siedor
  • District of New Jersey Denies Preliminary Injunction in Ustekinumab Breach of Contract Case May 2, 2025 Riley Wyberg
  • EmblemHealth Files Class Action Antitrust Against Alexion Related to Eculizumab April 30, 2025 Sam Herron
  • CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe April 30, 2025 Beth Ashbridge
  • Update on Regeneron’s Supplemental BLA for EYLEA HD April 29, 2025 Daniel Farraye
  • Regeneron, Mylan, and Biocon Settle in Aflibercept BPCIA Litigation April 28, 2025 Allegra Padula
  • Celltrion Adalimumab Biosimilar Granted Interchangeability Designation April 18, 2025 Zachariah Holmes
  • FDA to Phase Out Animal Testing for Monoclonal Antibodies and Other Drugs April 15, 2025 Darlene Staines

RSS BioPharma Reporter

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