Generalized Myasthenia Gravis

• FDA approval · 2026-03-26
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen.

• FDA approval · 2025-11-24
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen, a biosimilar to eculizumab.

• FDA approval · 2025-09-02
  FDA Approved: EPYSQLI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for EPYSQLI (eculizumab-aagh) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2025-03-12
  FDA Approved: EPYSQLI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for EPYSQLI (eculizumab-aagh), a biosimilar to eculizumab.

• FDA approval · 2025-01-30
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  FDA approved BKEMV (eculizumab-aeeb) under Amgen’s supplemental application, making a biosimilar to eculizumab available. The product is int…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-10-23
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen, updating its labeling and indications for this eculizuma…

• FDA approval · 2024-07-19
  FDA Approved: EPYSQLI — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved EPYSQLI (eculizumab-aagh) from Teva as a biosimilar to Soliris, for the same indications as the reference product.

• FDA approval · 2023-12-12
  FDA Approved: VYVGART — Supplemental Application (argenx US)

  FDA approved a supplemental application for Vyvgart (efgartigimod alfa) submitted by argenx US.

• FDA approval · 2023-10-17
  FDA Approved: ZILBRYSQ — Original Application (UCB, Inc.)

  The FDA approved ZILBRYSQ (zilucoplan) via its Original Application from UCB, Inc., for the treatment of generalized myasthenia gravis.

• FDA approval · 2023-06-26
  FDA Approved: RYSTIGGO — Original Application (UCB, Inc.)

  The FDA approved RYSTIGGO (rozanolixizumab) for the treatment of adults with generalized myasthenia gravis, marking the first approval of th…

• FDA approval · 2020-10-09
  FDA Approved: ULTOMIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Ultomiris (ravulizumab) submitted by Alexion Pharmaceuticals, resulting in changes to the la…

• FDA approval · 2019-06-27
  FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  The FDA approved a supplemental application for SOLIRIS (eculizumab) filed by Alexion Pharmaceuticals Inc., updating labeling to reflect the…

• FDA approval · 2012-12-21
  FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  FDA approved a supplemental application for SOLIRIS (eculizumab) submitted by Alexion Pharmaceuticals, resulting in changes to the product l…