Heart Transplantation
📧 Sign up to get email alerts when something new happens for Heart Transplantation.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2023-03-08FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Institutional LLC)
FDA issued a supplemental approval for mycophenolate mofetil in a filing by Mylan Institutional LLC.
-
FDA approval · 2022-12-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Lannett's generic mycophenolate mofetil, authorizing its market approval as a generic immunosupp…
-
FDA approval · 2021-10-22FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Cellcept (mycophenolate mofetil hydrochloride) submitted by Genentech, Inc.
-
FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Mycophenolate mofetil from Ascend Laboratories, LLC under ANDA 203005, indicating approval of a …
-
FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
FDA approved a supplemental application for a generic version of mycophenolate mofetil from Concord Biotech Limited.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2021-05-17FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's supplemental application for mycophenolate mofetil (ANDA 090253), allowing continued marketing of the gener…
-
FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Accord Healthcare Inc., authorizing the generic product's continued m…
-
FDA approval · 2021-01-15FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., reflecting a labeling update for this…
-
FDA approval · 2021-01-15FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Accord Healthcare Inc.'s mycophenolic acid, supporting its continued regulatory status as a gene…
-
CLINICAL_TRIALS trial_result · 2020-08-31Clinical Trial Update: Induction of Donor Specific Tolerance in Recipients of Cardiac Allografts by Donor Stem Cell Infusion [Phase 1, Phase 2]
A Phase 1/2 trial evaluating induction of donor-specific tolerance in heart transplant recipients via donor stem cell infusion; the study is…
-
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…
-
FDA approval · 2020-08-04FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Mycophenolate mofetil filed by Strides Pharma Science Limited.
-
CLINICAL_TRIALS trial_result · 2020-07-08Clinical Trial Update: Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients [Phase 4]
A Phase 4 clinical trial update on enteric-coated mycophenolate sodium (Myfortic) in heart transplant recipients with results posted.
-
FDA approval · 2019-10-22FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for tacrolimus (generic) under ANDA 091195, enabling continued approval of a …
-
CLINICAL_TRIALS trial_result · 2019-10-03Clinical Trial Update: SCHEDULE Follow Up Visit 5-7 yr [Phase 4]
Phase 4 follow-up results for a heart transplantation trial sponsored by Novartis have been completed with results posted in 2019.
-
FDA approval · 2019-09-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Accord Healthcare Inc.'s mycophenolate mofetil. This action updates the regulatory status for th…
-
CLINICAL_TRIALS trial_result · 2019-08-28Clinical Trial Update: Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation [Phase 2]
Phase 2 pharmacogenetic trial of tacrolimus after pediatric transplantation completed; results posted.
-
FDA approval · 2019-02-12FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (VistaPharm, LLC)
FDA approves VistaPharm, LLC's generic mycophenolate mofetil for prophylaxis of organ transplant rejection. This Original Application (ANDA …
-
FDA approval · 2019-01-31FDA Approved: TACROLIMUS — Original Application (Accord Healthcare Inc.)
The FDA approves Accord Healthcare Inc.'s Original Application for tacrolimus (generic tacrolimus) for prevention of organ transplant reject…
-
CLINICAL_TRIALS trial_result · 2019-01-23Clinical Trial Update: Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls
This completed clinical trial evaluated periodontal status and dental behavior in heart transplant recipients compared with healthy controls…
-
FDA approval · 2018-11-29FDA 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., expanding/…
-
CLINICAL_TRIALS withdrawal · 2018-11-19Clinical Trial Update: An Interventional Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients [Phase 3]
Phase 3 trial evaluating ivabradine for exercise capacity in heart transplant recipients was withdrawn.
-
CLINICAL_TRIALS trial_result · 2018-09-13Clinical Trial Update: Quantification of Intramyocardial Lipid by Proton Magnetic Resonance Spectroscopy [NA]
A completed clinical trial assessing quantification of intramyocardial lipid using proton magnetic resonance spectroscopy in heart transplan…
-
CLINICAL_TRIALS trial_result · 2018-06-25Clinical Trial Update: A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients [Phase 4]
Phase 4 trial comparing CNI-free versus standard regimen in new heart transplant recipients to assess renal tolerability, efficacy, and safe…
-
CLINICAL_TRIALS trial_result · 2018-06-15Clinical Trial Update: Multi-Drug Desensitization Protocol for Heart Transplant Candidates [Phase 2]
This Clinical Trial Update covers a Phase 2 study evaluating a multi-drug desensitization protocol for heart transplant candidates. The tria…