Lupus Nephritis
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-13EMA Authorised: Lupkynis (voclosporin) — Otsuka Pharmaceutical Netherlands B.V.
EMA authorised Lupkynis (voclosporin) for lupus nephritis, with Otsuka Pharmaceutical Netherlands B.V. as MAH; decision dated 11/08/2026.
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EMA approval · 2025-11-24EMA Authorised: Lupkynis (voclosporin) — Otsuka Pharmaceutical Netherlands B.V.
The European Medicines Agency authorized Lupkynis (voclosporin) for the treatment of lupus nephritis, marking EU approval for this therapy.
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FDA approval · 2025-10-08FDA Approved: LUPKYNIS — Supplemental Application (Aurinia Pharma U.S., Inc.)
FDA approved a supplemental application for LUPKYNIS (voclosporin) submitted by Aurinia Pharma U.S., Inc. This page documents the regulatory…
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FDA approval · 2025-06-27FDA Approved: MYHIBBIN — Supplemental Application (Azurity Pharmaceuticals, Inc.)
FDA approved a supplemental application for MYHIBBIN (mycophenolate mofetil) submitted by Azurity Pharmaceuticals, Inc. The supplement perta…
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FDA approval · 2024-10-22FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original application for a generic mycophenolate mofetil product.
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FDA approval · 2024-08-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Lannett Company, authorizing a generic version under ANDA 214525.
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FDA approval · 2024-08-09FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
The FDA approved a supplemental application for Accord Healthcare's generic mycophenolate mofetil.
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FDA approval · 2024-04-29FDA Approved: LUPKYNIS — Supplemental Application (Aurinia Pharma U.S., Inc.)
The FDA approved a supplemental application for LUPKYNIS (voclosporin) submitted by Aurinia Pharma U.S., Inc.
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FDA approval · 2022-12-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Lannett's generic mycophenolate mofetil, authorizing its market approval as a generic immunosupp…
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FDA approval · 2022-11-16FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited.
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FDA approval · 2021-10-22FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approves a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc.
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FDA approval · 2021-08-11FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Cellcept (mycophenolate mofetil) submitted by Genentech, Inc.
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for mycophenolate mofetil submitted by Hikma Pharmaceuticals USA Inc., updating the product info…
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for mycophenolate mofetil from Teva Pharmaceuticals USA, expanding its labeling.
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Mycophenolate mofetil from Ascend Laboratories, LLC under ANDA 203005, indicating approval of a …
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
The FDA approved a supplemental application for Mycophenolate mofetil (ANDA 065416) from Accord Healthcare Inc., updating the status of this…
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Mycophenolate mofetil from Mylan Pharmaceuticals Inc., updating the regulatory status for th…
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for Mycophenolate mofetil, submitted by Mylan Institutional LLC, potentially expanding labeling or i…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., updating or expanding its labeled ind…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for mycophenolate mofetil from Mylan Pharmaceuticals, indicating an approved change to the exist…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
FDA approved a supplemental application for mycophenolate mofetil by Concord Biotech Limited, enabling continued marketing of the immunosupp…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for mycophenolate mofetil from VistaPharm, LLC, enabling continued marketing of a generic versio…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Meitheal Pharmaceuticals Inc.)
FDA approves a supplemental application for mycophenolate mofetil from Meitheal Pharmaceuticals, reflecting an updated approval pathway for …
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Slate Run Pharmaceuticals, LLC)
FDA approved a supplemental application for mycophenolic acid from Slate Run Pharmaceuticals, LLC.
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FDA approval · 2021-01-22FDA Approved: LUPKYNIS — Original Application (Aurinia Pharma U.S., Inc.)
FDA approves LUPKYNIS (voclosporin) from Aurinia Pharma U.S., Inc. in an Original Application NDA for the treatment of active lupus nephriti…