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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Cliff Notes for New Interchangeability Draft Guidance by FDA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 Denial of Stelara Biosimilar Injunction May 11, 2026 Alison Siedor
  • FDA Approves Lannett, Lanexa Biologics, and Sunshine Lake Pharma’s Interchangeable Insulin Glargine Biosimilar May 11, 2026 Zachariah Holmes
  • FDA Issues Draft Guidance on Safety Testing for Gene Editing Therapies May 11, 2026 Allegra Padula
  • Amneal Agrees to Acquire Kashiv BioSciences for Total Payment up to $1.1 Billion May 4, 2026 Harrison Gunn
  • Eli Lilly to Acquire Kelonia Therapeutics May 4, 2026 Darlene Staines
  • Sun Pharma to Acquire Organon May 1, 2026 Darlene Staines
  • AbbVie Regulatory Submission and Deal News May 1, 2026 Gabriella Montes
  • Intellia Initiates Rolling BLA Submission for In Vivo CRISPR Therapy in Hereditary Angioedema April 28, 2026 Yoko Bian
  • Federal Circuit Reverses JMOL and Reinstates Jury Verdict in Teva v. Lilly April 25, 2026 Grace Truong
  • FDA Releases Congressional Justification for FY 2027 Budget, Including Proposal Regarding Interchangeability of Biosimilars April 22, 2026 Allegra Padula

RSS BioPharma Reporter

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