Invasive Aspergillosis

• CLINICAL_TRIALS trial_result · 2024-12-27
  Clinical Trial Update: T Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections After Allogeneic Stem Cell Transplantation [Phase 1, Phase 2]

  A completed Phase 1/2 trial evaluating donor-derived T lymphocytes for infections caused by adenovirus, cytomegalovirus, Epstein-Barr virus,…

• CLINICAL_TRIALS research · 2024-12-27
  Clinical Trial Update: Treatment Duration of IPA

  This ClinicalTrials.gov entry reports an update on treatment duration for invasive aspergillosis in a trial sponsored by Peking University P…

• FDA approval · 2024-12-23
  FDA Approved: POSACONAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' posaconazole under an Original Application (ANDA), marking a generic approval for this antifungal.

• CLINICAL_TRIALS research · 2024-12-13
  Clinical Trial Update: Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children [NA]

  An ongoing pediatric study evaluates therapeutic drug monitoring and pharmacokinetics of isavuconazole in children with invasive aspergillos…

• CLINICAL_TRIALS trial_result · 2024-11-20
  Clinical Trial Update: Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis [Phase 4]

  A Phase 4 post-marketing study evaluating the efficacy and safety of micafungin for invasive aspergillosis has been terminated.

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• CLINICAL_TRIALS trial_result · 2024-11-12
  Clinical Trial Update: Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

  A completed clinical trial evaluating diagnostic methods for invasive fungal disease in lung transplant recipients.

• FDA approval · 2024-10-25
  FDA Approved: NOXAFIL — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for NOXAFIL (posaconazole) from Merck Sharp & Dohme LLC.

• FDA approval · 2024-10-24
  FDA Approved: POSACONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for posaconazole (POSACONAZOLE), approving the generic product.

• CLINICAL_TRIALS research · 2024-09-03
  Clinical Trial Update: Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm [Phase 4]

  Phase 4 study evaluating individualized first maintenance doses of voriconazole using a multiparametric algorithm for invasive aspergillosis…

• CLINICAL_TRIALS trial_result · 2024-08-09
  Clinical Trial Update: Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis [Phase 2]

  Phase 2 trial evaluating safety and efficacy of coadministering ibrexafungerp with voriconazole in invasive aspergillosis was terminated, wi…

• CLINICAL_TRIALS trial_result · 2024-07-03
  Clinical Trial Update: Novel Biomarkers for Invasive Aspergillosis [NA]

  Clinical trial investigating novel biomarkers for invasive aspergillosis was terminated; no results reported in this update.

• CLINICAL_TRIALS trial_result · 2024-05-07
  Clinical Trial Update: Azole-echinocandin Combination Therapy for Invasive Aspergillosis [Phase 3]

  A Phase 3 trial evaluating azole-echinocandin combination therapy for invasive aspergillosis has been terminated.

• CLINICAL_TRIALS research · 2024-05-07
  Clinical Trial Update: Detection of Azole Resistance Inducing Mutations on DNA Extracted Directly From Serum or Plasma of Immunocompromised Patients With an Invasive Aspergillus Infection Azole Resistance PCR Optimalization-study

  This study aims to optimize PCR-based detection of azole-resistance mutations directly from serum or plasma in immunocompromised patients wi…

• CLINICAL_TRIALS research · 2024-04-29
  Clinical Trial Update: Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy

  A clinical trial conducted by University of Rome Tor Vergata is evaluating antifungal prophylaxis to prevent invasive aspergillosis in elder…

• FDA approval · 2024-04-03
  FDA Approved: VORICONAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for Voriconazole (generic), confirming its status as an approved generic antifunga…

• FDA approval · 2023-12-26
  FDA Approved: POSACONAZOLE — Original Application (Mylan Institutional LLC)

  FDA approves a generic posaconazole product from Mylan Institutional LLC under an Original Application (ANDA 211500). The approval indicates…

• FDA approval · 2023-12-08
  FDA Approved: CRESEMBA — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Cresemba (isavuconazonium sulfate) from Astellas Pharma US, Inc.

• FDA approval · 2023-12-08
  FDA Approved: CRESEMBA — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for CRESEMBA (isavuconazonium sulfate) submitted by Astellas Pharma US, Inc. The approval updates th…

• CLINICAL_TRIALS trial_result · 2023-09-21
  Clinical Trial Update: A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants [Phase 2]

  This update reports the results of a Phase 2 pediatric study evaluating isavuconazonium sulfate for invasive aspergillosis and invasive muco…

• FDA approval · 2023-08-28
  FDA Approved: POSACONAZOLE — Original Application (i3 Pharmaceuticals, LLC)

  FDA approved an original application for posaconazole from i3 Pharmaceuticals, LLC (generic posaconazole).

• FDA approval · 2023-08-08
  FDA Approved: VORICONAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for voriconazole from Zydus Lifesciences Limited, indicating an approval of the supplemental submiss…

• CLINICAL_TRIALS trial_result · 2023-05-19
  Clinical Trial Update: Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds [Phase 2]

  Phase 2 open-label study of APX001 (fosmanogepix) for invasive mold infections including Aspergillus; the trial was terminated and results w…

• FDA approval · 2023-03-09
  FDA Approved: VORICONAZOLE — Original Application (UBI Pharma Inc.)

  FDA approved a generic version of voriconazole (UBI Pharma Inc.) via Original Application. The approval covers treatment of certain invasive…

• FDA approval · 2022-12-14
  FDA Approved: VORICONAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Voriconazole from Sandoz Inc, approving a generic version of the antifungal medication.

• FDA approval · 2022-12-08
  FDA Approved: POSACONAZOLE — Original Application (NorthStar RxLLC)

  The FDA approved NorthStar RxLLC's original application for posaconazole, granting authorization for a generic posaconazole product (ANDA 21…