Aspergillosis
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CLINICAL_TRIALS trial_result · 2024-11-07Clinical Trial Update: Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp [Phase 4]
Phase 4 post-marketing study of micafungin for fungal infections caused by Candida and Aspergillus spp. has been terminated.
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FDA approval · 2024-10-24FDA Approved: ITRACONAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for itraconazole from Alembic Pharmaceuticals Inc., resulting in a label-related approval update for…
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CLINICAL_TRIALS trial_result · 2023-05-24Clinical Trial Update: ATCF (Azole Therapy in Cystic Fibrosis) [Phase 2]
Phase 2 clinical trial of azole therapy in cystic fibrosis patients with Aspergillus infections has completed.
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FDA approval · 2022-11-17FDA Approved: AMPHOTERICIN B — Original Application (Eugia US LLC)
FDA approved the original ANDA for Amphotericin B from Eugia US LLC, authorizing a generic Amphotericin B product.
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FDA approval · 2022-02-04FDA Approved: POSACONAZOLE — Original Application (Biocon Phama Inc.)
FDA approved Biocon Phama Inc.'s original application for posaconazole, authorizing a generic formulation of the antifungal agent.
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CLINICAL_TRIALS trial_result · 2021-07-19Clinical Trial Update: A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection [Phase 2, Phase 3]
A Phase 2/Phase 3 trial update evaluating a new posaconazole dosing regimen for paediatric patients with Cystic Fibrosis and Aspergillosis.
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CLINICAL_TRIALS trial_result · 2019-01-11Clinical Trial Update: Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101) [Phase 3]
Phase 3 trial assessing safety and efficacy of MK-5592 (Posaconazole) in Japanese participants with fungal infection (Aspergillosis) has com…
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CLINICAL_TRIALS trial_result · 2018-09-26Clinical Trial Update: To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early [Phase 3]
Phase 3 trial evaluating whether galactomannan testing can detect fungal infections earlier to enable earlier treatment in Aspergillosis.
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CLINICAL_TRIALS trial_result · 2018-05-01Clinical Trial Update: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of PC945 [Phase 1]
Phase 1 study evaluating safety, tolerability, and pharmacokinetics of single and repeat doses of PC945 in subjects with Aspergillosis has c…
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CLINICAL_TRIALS trial_result · 2017-03-23Clinical Trial Update: Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis [Phase 4]
A Phase 4 clinical trial evaluating treatment for Aspergillus fumigatus infection in cystic fibrosis patients has completed, with results po…
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CLINICAL_TRIALS trial_result · 2017-02-23Clinical Trial Update: Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043) [Phase 2]
A completed Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC investigating pediatric patients with documented Candida (Candidiasi…
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CLINICAL_TRIALS research · 2017-01-18Clinical Trial Update: Surveillance of Azole Resistance in Aspergillus Isolates in Taiwan
This clinical trial update describes surveillance of azole resistance in Aspergillus isolates collected in Taiwan.
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FDA approval · 2016-09-26FDA Approved: ITRACONAZOLE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's original application for itraconazole, granting a generic version of the antifungal medication. Th…
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FDA approval · 2015-10-30FDA Approved: ITRACONAZOLE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's original ANDA for itraconazole, enabling a generic version of the antifungal agent to be marketed.
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CLINICAL_TRIALS withdrawal · 2015-10-27Clinical Trial Update: UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients
A non-interventional observational trial (NCT01622595) evaluating infectious complications in cancer patients sponsored by the University of…
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CLINICAL_TRIALS trial_result · 2015-10-07Clinical Trial Update: Individualisation of Voriconazole Antifungal Therapy Antifungal Therapy [Phase 2]
A Phase 2 trial evaluating individualized voriconazole antifungal therapy has been suspended in immunocompromised patients with Aspergillosi…
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CLINICAL_TRIALS withdrawal · 2015-09-02Clinical Trial Update: A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis [Phase 4]
This Phase 4 trial evaluating voriconazole plus micafungin versus voriconazole alone for invasive aspergillosis has been withdrawn.
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CLINICAL_TRIALS trial_result · 2014-08-20Clinical Trial Update: Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis [Phase 2]
A Phase 2 trial evaluating micafungin in combination with liposomal amphotericin B for aspergillosis has been terminated.
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CLINICAL_TRIALS trial_result · 2014-05-09Clinical Trial Update: Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection [Phase 2]
A Phase 2 study evaluating the pharmacokinetics and safety of voriconazole in children aged 2 to less than 15 years at high risk for systemi…
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CLINICAL_TRIALS trial_result · 2014-04-23Clinical Trial Update: A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074) [Phase 2]
Phase 2 trial update for caspofungin in Japanese children and adolescents with Candida or Aspergillus infections completed with posted resul…
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CLINICAL_TRIALS research · 2013-08-26Clinical Trial Update: Early Diagnosis of Aspergillosis in Patients at High Risk of Fungal Infection Caused by Treatment for Hematologic Cancer or Other Disease [NA]
A clinical trial update on early diagnostic methods for aspergillosis in patients at high risk due to treatment for hematologic cancers or o…
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CLINICAL_TRIALS trial_result · 2013-07-25Clinical Trial Update: A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection [Phase 3]
Phase 3 pharmacokinetic study of the itraconazole oral solution JK1211 (Itrizole) in patients with invasive fungal infections; results have …
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CLINICAL_TRIALS trial_result · 2013-06-19Clinical Trial Update: Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal Infections [Phase 2]
Phase 2 trial evaluating voriconazole with or without interferon-gamma in patients with aspergillosis and other fungal infections; the study…
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CLINICAL_TRIALS trial_result · 2012-08-28Clinical Trial Update: An Observational Study of Fungal Biomarkers (MK-0000-089)
An observational study evaluating fungal biomarkers in patients with aspergillosis; the trial MK-0000-089 has completed and results were pos…
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FDA approval · 2012-06-21FDA Approved: NOXAFIL — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for NOXAFIL (posaconazole) from Merck Sharp & Dohme LLC, indicating an update to the NDA under t…