Granulomatosis with Polyangiitis

• EMA approval · 2025-10-06
  EMA Authorised: Rixathon (rituximab) — Sandoz GmbH

  EMA authorised Rixathon (rituximab) by Sandoz as a biosimilar to Rituxan for several autoimmune and hematologic diseases, expanding access t…

• EMA approval · 2025-09-29
  EMA Authorised: Truxima (rituximab) — Celltrion Healthcare Hungary Kft.

  EMA authorised Truxima (rituximab) by Celltrion Healthcare Hungary Kft. as a biosimilar rituximab for several indications including Non-Hodg…

• EMA approval · 2025-08-05
  EMA Authorised: Riximyo (rituximab) — Sandoz GmbH

  EMA authorized the biosimilar Riximyo (rituximab) by Sandoz GmbH for multiple indications, including Non-Hodgkin lymphoma, rheumatoid arthri…

• EMA approval · 2025-01-31
  EMA Authorised: Tavneos (avacopan) — Vifor Fresenius Medical Care Renal Pharma France

  The European Medicines Agency authorised Tavneos (avacopan) for microscopic polyangiitis and granulomatosis with polyangiitis (Wegener's gra…

• FDA approval · 2024-06-03
  FDA Approved: TAVNEOS — Supplemental Application (ChemoCentryx, Inc.)

  The FDA approved a supplemental application for TAVNEOS (avacopan) submitted by ChemoCentryx, expanding its regulatory status for the treatm…

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• FDA approval · 2022-06-03
  FDA Approved: RIABNI — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for RIABNI (rituximab-arrx) from Amgen. The action updates RIABNI’s labeling to reflect its approved…

• FDA approval · 2021-12-02
  FDA Approved: RITUXAN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Rituxan (rituximab) filed by Genentech, Inc., resulting in updated labeling for the product.

• FDA approval · 2021-10-07
  FDA Approved: TAVNEOS — Original Application (ChemoCentryx, Inc.)

  FDA approved Tavneos (avacopan) from ChemoCentryx for adults with ANCA-associated vasculitis, in combination with standard therapy, includin…

• FDA approval · 2020-12-17
  FDA Approved: RIABNI — Original Application (Amgen, Inc)

  FDA approved RIABNI (rituximab-arrx) from Amgen as a biosimilar to rituximab via Original Application.

• FDA approval · 2019-07-23
  FDA Approved: RUXIENCE — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved Ruxience (rituximab-pvvr) from Pfizer as a biosimilar to rituximab, under an original application; the approval covers multiple…

• FDA approval · 2019-05-23
  FDA Approved: TRUXIMA — Supplemental Application (Cephalon, Inc.)

  FDA approved a supplemental application for TRUXIMA (rituximab-ABBS) submitted by Cephalon, Inc.

• FDA approval · 2019-04-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for azathioprine from Zydus Lifesciences Limited.

• FDA approval · 2019-01-18
  FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for a generic cyclophosphamide product. This marks approval of a generic formulation …

• FDA approval · 2017-06-22
  FDA Approved: RITUXAN HYCELA — Original Application (Genentech, Inc.)

  FDA approved RITUXAN HYCELA (rituximab and hyaluronidase) under an Original Application by Genentech. The subcutaneous formulation provides …

• FDA approval · 2009-10-16
  FDA Approved: RITUXAN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Rituxan (rituximab) from Genentech.