Organ Transplant Rejection
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-04-10EMA Authorised: Mycophenolate mofetil Teva (mycophenolate mofetil) — Teva Pharma B.V.
The European Medicines Agency authorised Teva's generic mycophenolate mofetil product for preventing organ transplant rejection, with decisi…
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EMA approval · 2026-04-10EMA Authorised: CellCept (mycophenolate mofetil) — Roche Registration GmbH
The European Medicines Agency authorized CellCept (mycophenolate mofetil) by Roche Registration GmbH for preventing graft rejection in trans…
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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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CLINICAL_TRIALS research · 2025-04-17Clinical Trial Update: Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY) [Phase 2]
Phase 2 CINERGY trial evaluating whether administering a calcineurin inhibitor to neurologically deceased donors can reduce delayed graft fu…
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CLINICAL_TRIALS research · 2025-03-27Clinical Trial Update: Endothelial Glycocalyx Damage in Brain Death Organ Donors
This clinical trial update covers ongoing research on endothelial glycocalyx damage in brain-dead organ donors and notes that the study is a…
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EMA approval · 2025-02-27EMA Authorised: Advagraf (tacrolimus) — Astellas Pharma Europe BV
The EMA authorized Advagraf (tacrolimus) by Astellas Pharma Europe BV for prevention of graft rejection in organ transplant recipients.
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FDA approval · 2024-12-19FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Accord Healthcare's generic mycophenolic acid, expanding regulatory authorization for this produ…
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CLINICAL_TRIALS trial_result · 2024-10-15Clinical Trial Update: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3032 in Healthy Subjects [Phase 1]
Phase 1 study of SHR-3032 in healthy subjects completed to assess safety, tolerability, pharmacokinetics and pharmacodynamics for potential …
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FDA approval · 2024-08-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for mycophenolate mofetil filed by Hikma Pharmaceuticals USA Inc.
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FDA label_change · 2024-08-13FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Biocon Pharma Inc.)
FDA approved a supplemental application for Mycophenolic acid filed by Biocon Pharma Inc., updating the labeling for the product.
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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 · 2024-01-03FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
FDA granted a supplemental approval for a generic mycophenolate mofetil product from Ascend Laboratories, LLC.
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FDA approval · 2023-12-14FDA Approved: CYCLOSPORINE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approves Teva Pharmaceuticals' generic cyclosporine under an original application (ANDA 203880), expanding access to this immunosuppress…
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FDA approval · 2023-09-18FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
The FDA approved Accord Healthcare's supplemental application for mycophenolate mofetil, enabling the marketing of a generic version of this…
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FDA approval · 2022-08-10FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil hydrochloride) submitted by Genentech, Inc.
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FDA approval · 2021-11-03FDA Approved: MYCOPHENOLIC ACID — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved Upsher-Smith's original application for generic mycophenolic acid, an immunosuppressant used to prevent organ transplant reject…
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FDA approval · 2021-10-22FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved 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.)
FDA approved a supplemental application for CellCEPT (mycophenolate mofetil) submitted by Genentech, updating regulatory status for addition…
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FDA approval · 2021-06-04FDA Approved: TACROLIMUS — Supplemental Application (Stellon Biotech Inc.)
The FDA approved Stellon Biotech Inc.'s supplemental application for tacrolimus (ANDA213112), updating the labeling for this generic immunos…
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FDA approval · 2021-05-17FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., approving changes to the product'…
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FDA approval · 2021-04-21FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approves a supplemental application for CellCept (mycophenolate mofetil) from Genentech.
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FDA approval · 2021-01-15FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Archis Pharma LLC)
The FDA approved Archis Pharma LLC's supplemental application for mycophenolic acid (generic), indicating an approved modification to the ma…
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FDA approval · 2020-09-16FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)
FDA approved a supplemental application for ENVARSUS XR (Tacrolimus) submitted by Veloxis Pharmaceuticals, Inc.
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FDA approval · 2020-09-02FDA Approved: PREDNISONE — Original Application (Strides Pharma Science Limited)
FDA approval of a generic prednisone (PREDNISONE) Original Application by Strides Pharma Science Limited.
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FDA approval · 2019-12-13FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc.