Kidney Transplant Rejection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-05-21FDA Approved: CYCLOSPORINE — Original Application (Devatis Inc.)
FDA approved Devatis Inc.'s cyclosporine as a generic drug under an original ANDA (ANDA209811).
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CLINICAL_TRIALS research · 2024-05-13Clinical Trial Update: PLATO - Medication Adherence in Transplant Recipients [NA]
Clinical trial PLATO assesses medication adherence in kidney transplant recipients; the study is currently active but not recruiting.
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CLINICAL_TRIALS trial_result · 2024-03-19Clinical Trial Update: Desensitization in Kidney Allograft Using Daratumumab [Phase 1, Phase 2]
Phase 1/2 trial evaluating desensitization in kidney transplantation using daratumumab has been completed.
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CLINICAL_TRIALS trial_result · 2024-02-28Clinical Trial Update: An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients [Phase 2]
Phase 2 trial updating efficacy and safety of imlifidase for antibody-mediated rejection in kidney transplant patients has completed with re…
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FDA approval · 2024-02-20FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for a generic version of mycophenolate mofetil (Aurobindo Pharma Limited) to prevent organ transplant …
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FDA approval · 2024-01-25FDA Approved: TACROLIMUS — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved TACROLIMUS under Original Application from Amneal Pharmaceuticals NY LLC, including standard and extended-release capsule formu…
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FDA approval · 2024-01-05FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for mycophenolate mofetil from Aurobindo Pharma Limited, authorizing the generic immunosuppressant for…
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FDA approval · 2024-01-03FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' supplemental application for mycophenolate mofetil (ANDA 091249).
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CLINICAL_TRIALS trial_result · 2023-12-04Clinical Trial Update: Immune Monitoring to Facilitate Belatacept Monotherapy [Phase 4]
A Phase 4 clinical trial update on immune monitoring to facilitate belatacept monotherapy in kidney transplant patients; results posted afte…
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FDA approval · 2023-11-29FDA Approved: MYCOPHENOLIC ACID — Original Application (Biocon Pharma Inc.)
FDA approved mycophenolic acid from Biocon Pharma Inc. via an original application. It is indicated to prevent organ transplant rejection in…
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FDA approval · 2023-09-14FDA Approved: ASTAGRAF XL — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for ASTAGRAF XL (tacrolimus extended-release capsules) from Astellas Pharma US, Inc.
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FDA approval · 2023-06-22FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Meitheal Pharmaceuticals Inc.)
FDA approved a supplemental application for mycophenolate mofetil filed by Meitheal Pharmaceuticals Inc. The approval relates to an addition…
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FDA approval · 2023-06-22FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (ONESOURCE SPECIALTY PHARMA LIMITED)
FDA approved a supplemental application for mycophenolate mofetil submitted by Onesource Specialty Pharma Limited.
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CLINICAL_TRIALS trial_result · 2023-05-24Clinical Trial Update: Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients [Phase 4]
Phase 4 clinical trial update on enteric-coated mycophenolate sodium (EC-MPS) assessing efficacy and safety in de novo kidney transplant rec…
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FDA approval · 2023-04-19FDA Approved: TACROLIMUS — Supplemental Application (Ascend Laboratories, LLC)
The FDA has approved a supplemental application for tacrolimus from Ascend Laboratories, LLC.
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CLINICAL_TRIALS trial_result · 2023-03-03Clinical Trial Update: A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation [Phase 3]
Phase 3 trial comparing FCR001 to standard of care in de novo living donor kidney transplantation was terminated.
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FDA approval · 2022-12-23FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (ONESOURCE SPECIALTY PHARMA LIMITED)
FDA approved an original application for mycophenolate mofetil, a generic immunosuppressant used to prevent organ transplant rejection.
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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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CLINICAL_TRIALS trial_result · 2022-11-09Clinical Trial Update: Belatacept Conversion in Proteinuric Kidney Transplant Recipients [Phase 2]
Phase 2 clinical trial update on converting to belatacept in proteinuric kidney transplant recipients; results posted.
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FDA approval · 2022-08-10FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CellCept (mycophenolate mofetil) filed by Genentech, updating the labeling to reflect the approv…
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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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CLINICAL_TRIALS trial_result · 2022-07-18Clinical Trial Update: Induction of Donor Specific Tolerance in Recipients of Live Donor Kidney Allografts by Donor Stem Cell Infusion [Phase 1, Phase 2]
Phase 1/2 trial investigating donor stem cell infusion to induce donor-specific tolerance in recipients of live donor kidney allografts.
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FDA approval · 2022-03-08FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for mycophenolate mofetil (generic) submitted by Mylan Pharmaceuticals, granting approval under an A…
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FDA approval · 2021-11-29FDA Approved: MYCOPHENOLIC ACID — Original Application (Biocon Pharma Inc.)
FDA approved an original application for mycophenolic acid (Biocon Pharma Inc.), establishing a generic version of the immunosuppressant.
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FDA approval · 2021-10-22FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved Genentech's supplemental application for CELLCEPT (mycophenolate mofetil).