Invasive Candidiasis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-10-25FDA Approved: NOXAFIL — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for NOXAFIL (posaconazole) from Merck Sharp & Dohme LLC.
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CLINICAL_TRIALS trial_result · 2024-10-09Clinical Trial Update: The Role of Interferon-gamma in Immune Responses to Invasive Candidiasis
A completed Mayo Clinic clinical trial evaluated the role of interferon-gamma in immune responses to invasive candidiasis. The study finding…
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CLINICAL_TRIALS other · 2024-08-28Clinical Trial Update: A B-D-Glucan Driven Antifungal Stewardship Approach for Invasive Candidiasis [NA]
Clinical trial update for a B-D-Glucan driven antifungal stewardship approach in invasive candidiasis shows the study has been terminated; n…
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CLINICAL_TRIALS research · 2024-08-02Clinical Trial Update: Candida PCR Diagnosis Strategy in Patients From Intensive Care Units [NA]
This clinical trial update describes a study evaluating a Candida PCR diagnostic strategy in ICU patients to improve detection of Candida in…
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CLINICAL_TRIALS trial_result · 2024-07-03Clinical Trial Update: Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) [Phase 3]
Phase 3 open-label study evaluating oral ibrexafungerp (SCY-078) for invasive candidiasis and candidemia caused by Candida auris was complet…
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CLINICAL_TRIALS trial_result · 2024-06-25Clinical Trial Update: Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis [Phase 2]
Phase 2 trial comparing oral ibrexafungerp (SCY-078) to standard-of-care after IV echinocandin in invasive candidiasis; study completed with…
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FDA approval · 2024-05-29FDA Approved: MICAFUNGIN — Original Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s original ANDA for micafungin, a generic antifungal. The approval covers indications including candidiasis …
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CLINICAL_TRIALS research · 2024-05-16Clinical Trial Update: Early Discontinuation of Empirical Antifungal Therapy and Biomarkers [NA]
This clinical trial update notes that the study evaluating early discontinuation of empirical antifungal therapy guided by biomarkers in inv…
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FDA approval · 2023-12-26FDA 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…
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FDA approval · 2023-09-29FDA Approved: MICAFUNGIN IN SODIUM CHLORIDE — Original Application (Baxter Healthcare Corporation)
FDA approved a new intravenous micafungin sodium formulation under Baxter's Original Application NDA, expanding antifungal treatment options…
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FDA approval · 2023-07-14FDA Approved: FLUCONAZOLE — Supplemental Application (Baxter Healthcare Company)
FDA approved Baxter Healthcare Company's supplemental application for fluconazole (ANDA076766). This action confirms authorization of a gene…
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CLINICAL_TRIALS trial_result · 2023-05-08Clinical Trial Update: Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection. [Phase 3]
Phase 3 trial evaluating prophylactic fluconazole to prevent invasive fungal infection in preterm and very low birth weight neonates; study …
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FDA approval · 2023-03-22FDA Approved: REZZAYO — Original Application (Melinta Therapeutics, LLC)
FDA approved the original application for REZZAYO (rezafungin) by Melinta Therapeutics for the treatment of candidemia and invasive candidia…
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FDA approval · 2023-03-17FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for fluconazole submitted by Rising Pharma Holdings, Inc., indicating approval of a generic formulat…
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CLINICAL_TRIALS trial_result · 2023-01-09Clinical Trial Update: An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris [Phase 2]
Open-label Phase 2 trial evaluating APX001 (fosmanogepix) for candidemia and invasive candidiasis caused by Candida auris; study completed w…
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CLINICAL_TRIALS trial_result · 2023-01-06Clinical Trial Update: Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis [Phase 3]
Phase 3 trial comparing rezafungin to caspofungin in candidemia and invasive candidiasis has completed with results posted.
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FDA approval · 2022-10-24FDA Approved: MICAFUNGIN — Original Application (Northstar Rx LLC.)
FDA approved Northstar Rx LLC's original application for micafungin, a generic antifungal, for the treatment of invasive candidiasis includi…
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FDA approval · 2022-09-28FDA Approved: MICAFUNGIN — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved Meitheal Pharmaceuticals' original application for micafungin sodium (micafungin) injection, a generic antifungal, for trea…
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CLINICAL_TRIALS trial_result · 2022-08-11Clinical Trial Update: Evaluate Bioequivalence of Micafungin (50mg/Vial) [Phase 4]
Phase 4 trial update evaluating bioequivalence of micafungin 50 mg/vial in invasive candidiasis has completed.
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FDA approval · 2021-10-25FDA Approved: DIFLUCAN — Supplemental Application (Roerig)
The FDA approved a supplemental application for Diflucan (fluconazole) submitted by Roerig.
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FDA approval · 2021-07-09FDA Approved: MICAFUNGIN — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approves Hikma Pharmaceuticals USA Inc.'s original ANDA for micafungin sodium injectable (micafungin).
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FDA approval · 2021-07-09FDA Approved: MICAFUNGIN — Original Application (Sagent Pharmaceuticals)
FDA approved the Original Application for micafungin sodium from Sagent Pharmaceuticals, resulting in a generic micafungin product. The appr…
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FDA approval · 2021-06-16FDA Approved: MICAFUNGIN — Original Application (Par Health USA, LLC)
FDA approved a micafungin product via an original NDA submitted by Par Health USA, LLC.
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CLINICAL_TRIALS trial_result · 2021-04-12Clinical Trial Update: Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin [Phase 4]
A Phase 4 trial comparing two diagnostic tests in patients with suspected invasive candidiasis who are being treated with micafungin; the st…
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CLINICAL_TRIALS trial_result · 2020-12-08Clinical Trial Update: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension [Phase 2]
Phase 2 trial comparing CD101 to caspofungin followed by oral step-down in candidemia and invasive candidiasis completed; results posted.