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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Cliff Notes for New Interchangeability Draft Guidance by FDA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

  • Biocon Enters Ten-Year Pertuzumab Supply Contract in Brazil September 10, 2026 Darlene Staines
  • Eli Lilly to Acquire Merida Biosciences September 3, 2026 Emma Murray
  • AbbVie Submits Regulatory Application to EMA for Subcutaneous SKYRIZI® September 3, 2026 Emma Murray
  • Takeda Files BPCIA Suit Against Alvotech for Vedolizumab Biosimilar September 3, 2026 Emma Murray
  • Alvotech and Lotus Enter Agreement for Durvalumab and Emicizumab Biosimilars August 31, 2026 Yoko Bian
  • FDA Approves Ultragenyx’s GENGLYCOS™ Gene Therapy for GSDIa August 31, 2026 Yoko Bian
  • FDA approves Regeneron’s PASATRU™ (garetosmab-grts) for Fibrodysplasia Ossificans Progressiva August 28, 2026 Shauna Perigo
  • FDA Addresses FAQs on Developing Potential Cellular and Gene Therapy Products August 28, 2026 Michael Shriner
  • Takeda Files BPCIA Suit Against Polpharma Biologics For Vedolizumab Biosimilar August 28, 2026 Michael Shriner
  • Biocon Announces Supplemental U.S. FDA Approval for Prefilled Autoinjector for YESINTEK August 28, 2026 Allegra Padula

RSS BioPharma Reporter

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