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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Cliff Notes for New Interchangeability Draft Guidance by FDA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

  • FDA Approves Shanghai Henlius Biotech IND for Cetuximab Biosimilar May 22, 2026 Natasha Daughtrey
  • FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria; Janssen Seeks a Preliminary Injunction to Block Their Launch May 22, 2026 Sarah Adam
  • International Biosimilars Updates May 15, 2026 Riley Wyberg
  • 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  • FDA Issues Draft Guidance on Safety Testing for Gene Editing Therapies May 11, 2026 Allegra Padula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

RSS BioPharma Reporter

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