Myasthenia Gravis
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-21EMA Authorised: Imaavy (nipocalimab) — Janssen Cilag International NV
EMA has authorised Imaavy (nipocalimab) for myasthenia gravis, with Janssen Cilag International NV as the marketing authorization holder.
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EMA approval · 2026-08-21EMA Authorised: Rystiggo (rozanolixizumab) — UCB Pharma
Rystiggo (rozanolixizumab) has been authorised in the EU for myasthenia gravis by UCB Pharma.
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EMA approval · 2026-08-21EMA Authorised: Zilbrysq (zilucoplan) — UCB Pharma S.A.
Zilbrysq (zilucoplan) has been authorised by the EMA for use in myasthenia gravis.
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EMA approval · 2026-04-23EMA Authorised: Zilbrysq (zilucoplan) — UCB Pharma S.A.
The EMA authorised Zilbrysq (zilucoplan) from UCB Pharma S.A. for the treatment of myasthenia gravis. This marks regulatory approval for thi…
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FDA approval · 2026-02-26FDA Approved: VYVGART HYTRULO — Supplemental Application (argenx US)
The FDA approved a supplemental application for Vyvgart HYTRULO (efgartigimod alfa and hyaluronidase) submitted by argenx US.
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EMA approval · 2026-01-23EMA Authorised: Vyvgart (efgartigimod alfa) — Argenx
The European Medicines Agency has authorised Vyvgart (efgartigimod alfa) for the treatment of myasthenia gravis and chronic inflammatory dem…
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EMA approval · 2026-01-16EMA Authorised: Rystiggo (rozanolixizumab) — UCB Pharma
The European Medicines Agency authorised Rystiggo (rozanolixizumab) for myasthenia gravis, with orphan medicine designation.
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EMA approval · 2025-12-12EMA Authorised: Imaavy (nipocalimab) — Janssen Cilag International NV
The European Medicines Agency has authorised Imaavy (nipocalimab) for the treatment of myasthenia gravis, on behalf of Janssen Cilag Interna…
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FDA approval · 2025-10-17FDA Approved: VYVGART HYTRULO — Supplemental Application (argenx US)
FDA approved a supplemental application for Vyvgart Hytrulo, the fixed-dose combination of efgartigimod alfa and hyaluronidase (human recomb…
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FDA approval · 2025-10-17FDA Approved: VYVGART — Supplemental Application (argenx US)
The FDA approved a supplemental application for Vyvgart (efgartigimod alfa) submitted by argenx US.
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FDA approval · 2025-09-26FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Surgeon General-Department of the Army (TSG-DA))
FDA approved a supplemental application for pyridostigmine bromide submitted by the Surgeon General-Department of the Army (TSG-DA).
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FDA approval · 2025-06-13FDA Approved: AZATHIOPRINE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for azathioprine from Ascend Laboratories, LLC.
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FDA approval · 2024-10-25FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for Neostigmine Methylsulfate submitted by Eugia US LLC.
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FDA approval · 2024-10-04FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Surgeon General-Department of the Army (TSG-DA))
The FDA approved a supplemental application for pyridostigmine bromide, with involvement of the Surgeon General-Department of the Army, upda…
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FDA approval · 2024-10-04FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved pyridostigmine bromide from Amneal Pharmaceuticals under an original application for use in treating myasthenia gravis.
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FDA approval · 2024-09-19FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)
The FDA approved a supplemental application for SOLIRIS (eculizumab) filed by Alexion Pharmaceuticals, resulting in updated labeling that ma…
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FDA approval · 2024-08-08FDA Approved: VYVGART — Supplemental Application (argenx US)
FDA approved a supplemental Biologics License Application for VYVGART (efgartigimod alfa) by argenx US, resulting in a label/indication upda…
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FDA approval · 2024-08-08FDA Approved: VYVGART HYTRULO — Supplemental Application (argenx US)
The FDA approved a supplemental application for Vyvgart Hytrulo, a combination of efgartigimod alfa and recombinant hyaluronidase, submitted…
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FDA approval · 2024-06-21FDA Approved: VYVGART HYTRULO — Supplemental Application (argenx US)
The FDA approved a supplemental application for VYVGART HYTRULO (efgartigimod alfa and hyaluronidase) submitted by argenx US.
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FDA approval · 2024-06-14FDA Approved: RYSTIGGO — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for RYSTIGGO (rozanolixizumab) from UCB, Inc., supporting an updated indication or labeling.
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FDA approval · 2024-05-28FDA Approved: BKEMV — Original Application (Amgen Inc)
FDA approved BKEMV (eculizumab-aeeB), a biosimilar to eculizumab, developed by Amgen. The approval covers the same indications as the refere…
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FDA approval · 2023-11-02FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Eugia US LLC)
FDA approved the original application (ANDA 213244) for Neostigmine methylsulfate by Eugia US LLC, authorizing its generic entry and labelin…
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FDA approval · 2023-09-21FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Novadoz Pharmaceuticals LLC)
The FDA approved pyridostigmine bromide as a generic under an Original Application from Novadoz Pharmaceuticals LLC. It is indicated for the…
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FDA approval · 2023-06-20FDA Approved: VYVGART HYTRULO — Original Application (argenx US)
The FDA approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase, human recombinant) under an Original Application from argenx US. It i…
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FDA approval · 2022-11-25FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved an original ANDA for Neostigmine methylsulfate from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.), a generic versi…