Kidney Transplantation
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-06-04EMA Authorised: Rapamune (sirolimus) — Pfizer Europe MA EEIG
European Medicines Agency authorises Rapamune (sirolimus) for graft rejection and kidney transplantation.
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EMA approval · 2025-12-19EMA Authorised: Simulect (basiliximab) — Novartis Europharm Limited
The EMA has authorised Simulect (basiliximab) for use in preventing graft rejection in kidney transplantation, with Novartis Europharm Limit…
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EMA approval · 2025-09-17EMA Authorised: Rapamune (sirolimus) — Pfizer Europe MA EEIG
The EMA authorised Rapamune (sirolimus) for preventing graft rejection in kidney transplantation.
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EMA approval · 2025-07-02EMA Authorised: Idefirix (imlifidase) — Hansa Biopharma AB
The EMA authorised Idefirix (imlifidase) from Hansa Biopharma AB for desensitization to enable kidney transplantation in highly sensitised p…
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FDA approval · 2025-06-27FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approves a supplemental application for CellCept (mycophenolate mofetil hydrochloride) from Genentech, confirming an approved modificati…
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FDA approval · 2025-05-19FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for tacrolimus filed by Accord Healthcare Inc. under ANDA 091195 for the generic product.
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EMA approval · 2025-05-08EMA Authorised: Tacforius (tacrolimus monohydrate) — Teva B.V.
The EMA authorised Tacforius, tacrolimus monohydrate, by Teva B.V. for use in liver and kidney transplantation.
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FDA approval · 2024-08-13FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for MYFORTIC (mycophenolic acid) from Novartis. The approval expands its use for preventing orga…
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FDA approval · 2024-08-13FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Mycophenolic Acid submitted by Aurobindo Pharma Limited under an ANDA, approving changes to …
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FDA approval · 2024-08-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (ONESOURCE SPECIALTY PHARMA LIMITED)
FDA approved a supplemental application for mycophenolate mofetil submitted by Onesource Specialty Pharma Limited. The action pertains to ch…
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FDA approval · 2024-08-13FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s supplemental application for mycophenolic acid, granting approval of the generic product under ANDA214630.…
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FDA approval · 2024-07-08FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited, enabling approval of a generic formulation u…
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FDA approval · 2024-05-01FDA Approved: MYHIBBIN — Original Application (Azurity Pharmaceuticals, Inc.)
FDA approved MYHIBBIN, a mycophenolate mofetil product from Azurity Pharmaceuticals, under an original application (NDA216482). This approva…
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FDA approval · 2024-02-27FDA Approved: MYCOPHENOLIC ACID — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for generic mycophenolic acid from Aurobindo Pharma Limited. It is indicated as part of an immunosuppr…
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FDA approval · 2024-02-07FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for a generic version of mycophenolate mofetil from Hikma Pharmaceuticals USA, enabling continue…
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FDA approval · 2023-09-14FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for PROGRAF (tacrolimus) submitted by Astellas Pharma US, Inc.
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FDA approval · 2023-09-14FDA Approved: ZORTRESS — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approves a supplemental application for ZORTRESS (everolimus) from Novartis Pharmaceuticals Corporation, expanding its approved indicati…
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FDA approval · 2023-09-14FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for PROGRAF (tacrolimus) from Astellas, updating the labeling for its use as an immunosuppressant to…
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FDA approval · 2023-05-08FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for mycophenolate mofetil from Ascend Laboratories, LLC under ANDA203005.
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FDA approval · 2023-05-01FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
The FDA approved a supplemental application for tacrolimus by Sandoz Inc., resulting in a supplemental approval for the generic product. Thi…
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FDA approval · 2023-03-08FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Institutional LLC)
FDA issued a supplemental approval for mycophenolate mofetil in a filing by Mylan Institutional LLC.
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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 · 2021-10-22FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Cellcept (mycophenolate mofetil hydrochloride) submitted by Genentech, Inc.
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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 (CONCORD BIOTECH LIMITED)
FDA approved a supplemental application for a generic version of mycophenolate mofetil from Concord Biotech Limited.