Kidney Transplant Rejection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-08-23FDA Approved: MYCOPHENOLIC ACID — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s original application for mycophenolic acid, enabling its generic use as an immunosuppressant to preven…
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FDA approval · 2017-05-09FDA Approved: NULOJIX — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for NULOJIX (belatacept) submitted by E.R. Squibb & Sons, L.L.C.
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CLINICAL_TRIALS trial_result · 2017-04-25Clinical Trial Update: A Study of Belimumab in the Prevention of Kidney Transplant Rejection [Phase 2]
Phase 2 study evaluating belimumab to prevent kidney transplant rejection has completed, with results posted in 2017.
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CLINICAL_TRIALS trial_result · 2017-04-07Clinical Trial Update: Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection
This is a completed non-interventional study evaluating tacrolimus Sandoz capsules for prophylaxis of renal graft rejection.
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CLINICAL_TRIALS trial_result · 2017-03-23Clinical Trial Update: Bortezomib in Late Antibody-mediated Kidney Transplant Rejection [Phase 2]
A Phase 2 trial evaluating bortezomib for late antibody-mediated rejection in renal transplant recipients has completed.
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FDA approval · 2017-02-02FDA 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.
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FDA approval · 2017-01-06FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)
FDA processed a supplemental approval for ENVARSUS XR (tacrolimus) from Veloxis Pharmaceuticals, potentially expanding its labeling or indic…
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FDA approval · 2016-10-28FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Endo USA, Inc.)
FDA approves Endo USA, Inc.'s generic mycophenolate mofetil original application (ANDA 203575), enabling its use to prevent organ transplant…
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CLINICAL_TRIALS research · 2016-08-12Clinical Trial Update: European Transplant Registry of Senior Renal Transplant Recipients on Advagraf
Clinical trial update for a European registry study of senior renal transplant recipients on Advagraf (tacrolimus extended-release) with not…
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FDA approval · 2016-08-01FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Mycophenolate mofetil from Strides Pharma Science Limited under an ANDA.
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FDA approval · 2016-08-01FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for the generic drug Mycophenolate mofetil from Strides Pharma Science Limited, finalizing changes t…
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FDA approval · 2016-06-22FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)
The FDA approved a supplemental application for ENVARSUS XR (tacrolimus) submitted by Veloxis Pharmaceuticals, Inc., adding/updating its ind…
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FDA approval · 2016-06-07FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)
The FDA approved a supplemental application for ENVARSUS XR (tacrolimus) submitted by Veloxis Pharmaceuticals, Inc. The approval is for the …
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FDA approval · 2016-05-26FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc. The action authorizes changes unde…
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CLINICAL_TRIALS trial_result · 2016-03-09Clinical Trial Update: Reference Group Trial for The ONE Study [Phase 4]
A Phase 4 reference group trial for The ONE Study sponsored by the University of Regensburg has completed, involving patients with end-stage…
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FDA approval · 2016-01-22FDA Approved: TACROLIMUS — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for tacrolimus from Strides Pharma Science Limited.
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CLINICAL_TRIALS research · 2015-12-04Clinical Trial Update: Renal Transplantation in the Elderly - nEverOld Study [Phase 4]
Phase 4 clinical trial update describing the nEverOld study on renal transplantation in elderly patients. Sponsored by the University of Sao…
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FDA approval · 2015-11-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
The FDA approved a supplemental application for Accord Healthcare's mycophenolate mofetil, a generic immunosuppressant, to support its use i…
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FDA approval · 2015-11-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for mycophenolate mofetil submitted by Ascend Laboratories, LLC.
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FDA approval · 2015-11-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for mycophenolate mofetil from Ascend Laboratories, LLC.
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FDA approval · 2015-11-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application to allow Strides Pharma Science Limited to market a generic mycophenolate mofetil. This approval…
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FDA approval · 2015-11-09FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for mycophenolate mofetil from Sandoz Inc under an ANDA, authorizing changes to the product labeling…
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FDA approval · 2015-11-06FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's supplemental application for mycophenolate mofetil (generic) under an existing ANDA.
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FDA label_change · 2015-11-06FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA supplemental approval for mycophenolate mofetil by Accord Healthcare Inc., resulting in labeling changes for the product.
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FDA approval · 2015-10-30FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for mycophenolate mofetil, enabling generic manufacturing and marketi…