Kidney Transplant Rejection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-05-07FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
FDA approved Sandoz's supplemental application for tacrolimus, making a generic tacrolimus product available for preventing organ transplant…
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FDA approval · 2013-04-08FDA Approved: NULOJIX — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for NULOJIX (belatacept) submitted by E.R. Squibb & Sons, L.L.C., marking an additional regulato…
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FDA approval · 2013-02-14FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) from Genentech, Inc.
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FDA approval · 2013-02-14FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for CellCept (mycophenolate mofetil) submitted by Genentech, Inc., updating the labeling to refl…
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FDA approval · 2013-02-07FDA Approved: SANDIMMUNE — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for SANDIMMUNE (cyclosporine) from Novartis, indicating updated labeling or expanded use via a suppl…
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FDA approval · 2012-10-12FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
The FDA approved a supplemental application for tacrolimus submitted by Sandoz Inc.
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FDA approval · 2012-09-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for mycophenolate mofetil from Sandoz Inc, authorizing changes to the product as part of the sup…
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FDA approval · 2012-09-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for mycophenolate mofetil submitted by Mylan Pharmaceuticals Inc. The action updates the product's l…
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FDA approval · 2012-09-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for Mycophenolate mofetil from Strides Pharma Science Limited, enabling the generic product to b…
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FDA approval · 2012-09-10FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)
FDA approves a supplemental application for tacrolimus from Accord Healthcare Inc., resulting in updated labeling and/or indications for the…
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FDA approval · 2012-07-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., resulting in changes to the approved …
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FDA approval · 2012-07-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., indicating a modification to an a…
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CLINICAL_TRIALS trial_result · 2012-07-09Clinical Trial Update: Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults [Phase 1, Phase 2]
This clinical trial update reports results from a Phase 1/2 study of a combination immunosuppressive therapy intended to prevent kidney tran…
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FDA approval · 2012-06-28FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for tacrolimus (generic) to update the product, which is used to prevent orga…
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FDA approval · 2012-06-27FDA Approved: TACROLIMUS — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for tacrolimus submitted by Quallent Pharmaceuticals Health LLC.
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CLINICAL_TRIALS withdrawal · 2012-02-17Clinical Trial Update: Recombinant Human C1 Inhibitor for the Treatment of Early Antibody-Mediated Rejection in Renal Transplantation [Phase 2]
A Phase 2 trial evaluating recombinant human C1 esterase inhibitor for early antibody-mediated rejection in kidney transplantation has been …
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CLINICAL_TRIALS trial_result · 2012-01-31Clinical Trial Update: Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients [Phase 4]
Phase 4 trial evaluating two sirolimus-based immunosuppressive regimens in elderly kidney transplant recipients has completed.
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FDA approval · 2011-11-28FDA Approved: TACROLIMUS — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for tacrolimus from Quallent Pharmaceuticals Health LLC to support continued marketing of the im…
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FDA approval · 2011-11-18FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
FDA approved a supplemental application for tacrolimus submitted by Sandoz Inc. (ANDA065461), authorizing a tacrolimus product as part of th…
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CLINICAL_TRIALS trial_result · 2011-11-18Clinical Trial Update: Treatment of Children With Kidney Transplants by Injection of CD4+CD25+FoxP3+ T Cells to Prevent Organ Rejection [Phase 1, Phase 2]
This document reports a Phase 1/2 clinical trial evaluating injections of regulatory T cells (CD4+CD25+FoxP3+ T cells) to prevent organ reje…
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CLINICAL_TRIALS trial_result · 2011-11-07Clinical Trial Update: Belatacept to Prevent Organ Rejection in Kidney Transplant Patients [Phase 2]
A Phase 2 clinical trial evaluating belatacept to prevent rejection in kidney transplant patients was terminated, and results were posted in…
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FDA approval · 2011-11-04FDA Approved: TACROLIMUS — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved a supplemental application for tacrolimus submitted by Padagis Israel Pharmaceuticals Ltd.
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FDA approval · 2011-11-04FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' original ANDA for a generic version of mycophenolate mofetil, confirming bioequivalence to the referen…
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FDA approval · 2011-09-27FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
FDA approved a supplemental application for tacrolimus from Sandoz Inc. This action concerns the generic tacrolimus product.
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FDA approval · 2011-07-14FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for PROGRAF (tacrolimus) from Astellas Pharma US, Inc., potentially updating or expanding labeli…