Organ Transplantation

• CLINICAL_TRIALS trial_result · 2025-11-21
  Clinical Trial Update: PK Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®) [Phase 4]

  Phase 4 clinical trial update evaluating tacrolimus exposure before and after switching from twice-daily immediate-release Prograf to once-d…

• FDA approval · 2025-09-04
  FDA Approved: TACROLIMUS — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application from Amneal Pharmaceuticals NY LLC for tacrolimus and tacrolimus extended-release capsules, expa…

• FDA approval · 2025-07-15
  FDA Approved: SIROLIMUS — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings, Inc.'s original application for sirolimus, a generic immunosuppressant used to prevent organ transp…

• CLINICAL_TRIALS trial_result · 2025-03-13
  Clinical Trial Update: Outcomes of Empiric Antibiotic Therapy Based on Hospital Antibiograms in Organ Transplant Recipients with Bacteraemia

  This clinical trial evaluates outcomes of empiric antibiotic therapy guided by hospital antibiograms in organ transplant recipients with bac…

• EMA approval · 2025-02-28
  EMA Authorised: Envarsus (tacrolimus) — Chiesi Farmaceutici S.p.A.

  The EMA authorised Envarsus (tacrolimus) by Chiesi Farmaceutici S.p.A. for prevention of graft rejection in organ transplantation.

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• EMA approval · 2025-02-27
  EMA Authorised: Advagraf (tacrolimus) — Astellas Pharma Europe BV

  The EMA authorized Advagraf (tacrolimus) by Astellas Pharma Europe BV for prevention of graft rejection in organ transplant recipients.

• CLINICAL_TRIALS research · 2024-11-08
  Clinical Trial Update: Survey on the Evaluation of Medication Information Leaflets for Organ Transplant Patients

  A recruiting clinical trial surveying how organ transplant patients evaluate medication information leaflets.

• CLINICAL_TRIALS research · 2024-07-15
  Clinical Trial Update: Leuven Tolerogenic Protocol for Intestinal Transplantation

  Clinical trial update for Leuven's tolerogenic protocol in intestinal transplantation; study actively recruiting.

• FDA approval · 2023-09-26
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for NEORAL (cyclosporine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2022-11-22
  FDA Approved: ASTAGRAF XL — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA granted approval for a supplemental application for ASTAGRAF XL (tacrolimus extended-release capsules) to update/expand its labeling…

• FDA approval · 2021-09-23
  FDA Approved: MYCOPHENOLIC ACID — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for generic mycophenolic acid by Ascend Laboratories, authorizing its use to prevent organ transplant …

• CLINICAL_TRIALS trial_result · 2021-08-24
  Clinical Trial Update: The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation [Phase 3]

  A Phase 3 clinical trial evaluating the safety of Oka Varicella in children before solid organ transplantation has completed.

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  The FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited, resulting in approval of this generic im…

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  FDA approved a supplemental application for a generic version of mycophenolate mofetil from Concord Biotech Limited.

• CLINICAL_TRIALS trial_result · 2020-12-17
  Clinical Trial Update: Reducing the Burden of Influenza After Solid-Organ Transplantation [Phase 2, Phase 3]

  A clinical trial update on reducing the burden of influenza after solid-organ transplantation across Phase 2 and Phase 3 stages.

• FDA approval · 2020-08-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for a generic version of mycophenolate mofetil from Strides Pharma Science Limited.

• CLINICAL_TRIALS trial_result · 2020-01-30
  Clinical Trial Update: Belatacept Post Depletional Repopulation to Facilitate Tolerance [Phase 2]

  Phase 2 trial investigating belatacept post depletional repopulation aimed at facilitating transplant tolerance; study completed with result…

• FDA approval · 2018-12-19
  FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)

  The FDA approved a supplemental application for ENVARSUS XR (Tacrolimus) submitted by Veloxis Pharmaceuticals, Inc.

• CLINICAL_TRIALS trial_result · 2017-06-20
  Clinical Trial Update: Remote Ischemic Preconditioning in Neurological Death Organ Donors [NA]

  A completed clinical trial investigating remote ischemic preconditioning in neurological death organ donors; results posted in 2017.

• CLINICAL_TRIALS research · 2015-05-15
  Clinical Trial Update: To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks

  A terminated clinical trial evaluating a finger-prick dried blood spot method to measure tacrolimus concentrations in the blood of transplan…

• FDA approval · 2013-01-28
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for PROGRAF (tacrolimus) submitted by Astellas Pharma US, Inc., related to updating/expanding it…

• FDA approval · 2012-08-30
  FDA Approved: SANDIMMUNE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for SANDIMMUNE (cyclosporine) to update and expand its labeling.

• CLINICAL_TRIALS trial_result · 2009-02-17
  Clinical Trial Update: Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors [Phase 4]

  Phase 4 clinical trial update comparing gastrointestinal tolerability of mycophenolate mofetil (MMF) versus enteric-coated mycophenolate sod…

• FDA approval · 2007-12-27
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for cyclosporine from Apotex Corp. This action approves additional labeling or supply under the supp…