Lupus Nephritis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
The FDA approved a supplemental application for Mycophenolate mofetil (ANDA 065416) from Accord Healthcare Inc., updating the status of this…
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Mycophenolate mofetil from Mylan Pharmaceuticals Inc., updating the regulatory status for th…
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for Mycophenolate mofetil, submitted by Mylan Institutional LLC, potentially expanding labeling or i…
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CLINICAL_TRIALS trial_result · 2021-07-12Clinical Trial Update: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis [Phase 2]
A Phase 2 dose-finding study of BI 655064 in patients with active lupus nephritis has been completed, with results on efficacy and safety re…
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CLINICAL_TRIALS trial_result · 2021-06-16Clinical Trial Update: Aurinia Renal Response in Active Lupus With Voclosporin [Phase 3]
Phase 3 trial update on voclosporin for Lupus Nephritis completed with results posted in 2021.
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CLINICAL_TRIALS research · 2021-06-11Clinical Trial Update: A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis [Phase 2]
Phase II study investigating the efficacy and safety of SHR-1314 in lupus nephritis.
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CLINICAL_TRIALS trial_result · 2021-05-19Clinical Trial Update: Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis [Phase 2, Phase 3]
Phase 2/Phase 3 trial evaluating sirolimus for treatment of proteinuric flares in lupus nephritis.
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CLINICAL_TRIALS trial_result · 2021-05-18Clinical Trial Update: AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV) [Phase 2]
Phase 2 trial update for voclosporin in lupus nephritis (AURA-LV) has completed with results posted.
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., updating or expanding its labeled ind…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for mycophenolate mofetil from Mylan Pharmaceuticals, indicating an approved change to the exist…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
FDA approved a supplemental application for mycophenolate mofetil by Concord Biotech Limited, enabling continued marketing of the immunosupp…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for mycophenolate mofetil from VistaPharm, LLC, enabling continued marketing of a generic versio…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Meitheal Pharmaceuticals Inc.)
FDA approves a supplemental application for mycophenolate mofetil from Meitheal Pharmaceuticals, reflecting an updated approval pathway for …
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Slate Run Pharmaceuticals, LLC)
FDA approved a supplemental application for mycophenolic acid from Slate Run Pharmaceuticals, LLC.
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CLINICAL_TRIALS trial_result · 2021-03-19Clinical Trial Update: Aurinia Early Urinary Protein Reduction Predicts Response [Phase 2]
Phase 2 trial update suggests that early reduction in urinary protein predicts response in lupus nephritis.
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CLINICAL_TRIALS withdrawal · 2021-02-02Clinical Trial Update: Pentoxifylline in Lupus Nephritis [Phase 4]
Phase 4 trial of pentoxifylline for lupus nephritis has been withdrawn.
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CLINICAL_TRIALS trial_result · 2021-02-01Clinical Trial Update: Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis [Phase 4]
Phase 4 trial comparing fixed-dose versus concentration-controlled mycophenolate mofetil in active lupus nephritis has been terminated.
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FDA approval · 2021-01-22FDA Approved: LUPKYNIS — Original Application (Aurinia Pharma U.S., Inc.)
FDA approves LUPKYNIS (voclosporin) from Aurinia Pharma U.S., Inc. in an Original Application NDA for the treatment of active lupus nephriti…
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FDA label_change · 2021-01-15FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA issued a supplemental approval for mycophenolate mofetil (Hikma) to update the drug's labeling under an existing approval.
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FDA approval · 2021-01-15FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
FDA approved a supplemental application for a generic version of mycophenolate mofetil from Concord Biotech Limited.
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FDA approval · 2021-01-15FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
The FDA approved Concord Biotech Limited's supplemental application for mycophenolate mofetil, adding a new generic product (ANDA 212087) to…
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CLINICAL_TRIALS trial_result · 2020-12-22Clinical Trial Update: A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) [Phase 3]
Phase 3 trial evaluating ocrelizumab for nephritis due to systemic lupus erythematosus was terminated; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-09-04Clinical Trial Update: Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children [Phase 4]
Phase 4 trial update on low-dose versus high-dose IV cyclophosphamide for proliferative lupus nephritis in children; study terminated.
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FDA approval · 2020-08-04FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for mycophenolate mofetil, a generic immunosuppressant used to prevent organ transplant rejecti…
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CLINICAL_TRIALS trial_result · 2020-07-07Clinical Trial Update: Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis [Phase 3]
Phase 3 trial update on belimumab for active lupus nephritis reporting efficacy and safety results.