Kidney Transplant Rejection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-10-30FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for mycophenolate mofetil filed by Mylan Pharmaceuticals Inc. The action relates to the approved gen…
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FDA approval · 2015-10-13FDA Approved: TACROLIMUS — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for tacrolimus from Quallent Pharmaceuticals Health LLC, approving a generic formulation for use in …
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CLINICAL_TRIALS trial_result · 2015-09-09Clinical Trial Update: Impact of Proteasome Inhibition on Anti-Donor HLA Antibody Production After Kidney Transplantation [Phase 2]
A Phase 2 trial assessed proteasome inhibition to reduce anti-donor HLA antibody production after kidney transplantation; results were poste…
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FDA approval · 2015-08-12FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)
The FDA approved a supplemental application for ENVARSUS XR (tacrolimus) filed by Veloxis Pharmaceuticals, authorizing changes to the NDA vi…
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CLINICAL_TRIALS trial_result · 2015-08-03Clinical Trial Update: Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection [Phase 1, Phase 2]
Berinert (C1 esterase inhibitor) was studied in Phase 1/2 trials to prevent rejection in kidney transplant recipients. The update reports on…
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FDA approval · 2015-07-09FDA 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 · 2015-07-09FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CellCept (mycophenolate mofetil) submitted by Genentech, Inc.
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CLINICAL_TRIALS trial_result · 2015-05-12Clinical Trial Update: Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection [Phase 2]
Phase 2 study combining kidney transplantation with bone marrow to induce tolerance and prevent rejection; the trial completed with results …
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CLINICAL_TRIALS trial_result · 2015-01-15Clinical Trial Update: A Trial of Two Steroid-Free Approaches Toward Mycophenolate Mofetil-Based Monotherapy Immunosuppression [Phase 4]
Phase 4 clinical trial evaluating two steroid-free approaches to mycophenolate mofetil–based monotherapy immunosuppression in kidney transpl…
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FDA approval · 2014-11-14FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Ascend Laboratories, LLC)
FDA approved an original application for a generic version of mycophenolate mofetil from Ascend Laboratories, intended to prevent organ tran…
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FDA approval · 2014-10-27FDA Approved: SIROLIMUS — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved Dr. Reddy's Laboratories' original application for a generic sirolimus product, enabling its use as an immunosuppressant for tr…
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FDA approval · 2014-06-26FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Apotex Corp)
The FDA approved a supplemental application for mycophenolic acid from Apotex Corp.
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FDA approval · 2014-04-15FDA Approved: NULOJIX — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approves a supplemental application for NULOJIX (belatacept) from E.R. Squibb & Sons, L.L.C., under BLA125288.
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FDA approval · 2014-02-27FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
The FDA approved a supplemental application for tacrolimus from Sandoz Inc., a generic immunosuppressant used to prevent organ rejection in …
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FDA approval · 2014-01-23FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved Genentech's supplemental application for Cellcept (mycophenolate mofetil), under NDA 050722, confirming a change/update via…
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FDA approval · 2014-01-08FDA Approved: MYCOPHENOLIC ACID — Original Application (Archis Pharma LLC)
FDA approved Archis Pharma LLC's original application for mycophenolic acid, granting approval of a generic version for use in preventing or…
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FDA approval · 2014-01-08FDA Approved: SIROLIMUS — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approves an original generic application for sirolimus from Zydus Pharmaceuticals USA Inc., establishing a generic version of the immuno…
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FDA approval · 2013-09-27FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech.
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FDA label_change · 2013-09-27FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Myfortic (mycophenolic acid) from Novartis. The approval updates the labeling to reflect changes…
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FDA approval · 2013-09-27FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Sandoz Inc's mycophenolate mofetil.
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FDA approval · 2013-09-27FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for MYCOPHENOLATE MOFETIL by Accord Healthcare Inc., marking an update to its regulatory status rela…
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FDA approval · 2013-09-27FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Mycophenolate mofetil from Strides Pharma Science Limited under the ANDA program. This action au…
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CLINICAL_TRIALS trial_result · 2013-08-15Clinical Trial Update: Urine Testing to Detect Kidney Transplant Rejection
Completed clinical trial evaluating a urine test to detect kidney transplant rejection.
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CLINICAL_TRIALS trial_result · 2013-07-30Clinical Trial Update: Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients [Phase 4]
Phase 4 trial comparing bioavailability of mycophenolate mofetil products in stable renal transplant recipients; study terminated with resul…
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FDA approval · 2013-07-24FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved Genentech's supplemental application for CELLCEPT (mycophenolate mofetil), indicating an approved modification related to i…