Candidemia
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Sign up freeTop drugs studied for this disease
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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 · 2022-12-14FDA Approved: VORICONAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Voriconazole from Sandoz Inc, approving a generic version of the antifungal medication.
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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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FDA approval · 2022-06-13FDA Approved: VORICONAZOLE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for Voriconazole from Zydus Lifesciences Limited, updating the approval for this generic antifun…
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FDA approval · 2022-05-09FDA Approved: VORICONAZOLE — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved Meitheal Pharmaceuticals' original application for a generic voriconazole product, enabling marketing of a generic antifung…
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CLINICAL_TRIALS trial_result · 2021-08-05Clinical Trial Update: An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia [Phase 2]
Phase 2 trial evaluating APX001 for candidemia in non-neutropenic patients has completed and results have been posted, detailing efficacy an…
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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 · 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.
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FDA approval · 2020-10-05FDA Approved: ERAXIS — Supplemental Application (Roerig)
FDA approves a supplemental application for ERAXIS (anidulafungin) submitted by Roerig.
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FDA approval · 2020-07-31FDA Tentative Approval: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)
The FDA granted tentative approval for a supplemental application for Mycamine (micafungin sodium) from Astellas Pharma US, enabling potenti…
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FDA approval · 2020-06-22FDA Approved: FLUCONAZOLE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for fluconazole submitted by Chartwell RX, LLC.
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FDA approval · 2019-09-05FDA Approved: CASPOFUNGIN ACETATE — Supplemental Application (Sagent Pharmaceuticals)
FDA approved a supplemental application for Caspofungin acetate submitted by Sagent Pharmaceuticals.
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CLINICAL_TRIALS trial_result · 2019-07-08Clinical Trial Update: Negative Beta Glucan in ICU Patients [Phase 4]
Phase 4 clinical trial update evaluating negative beta-glucan in ICU patients with candidemia; results posted after completion.
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FDA approval · 2019-05-17FDA Approved: MICAFUNGIN — Original Application (Fresenius Kabi USA, LLC)
FDA approves Fresenius Kabi USA, LLC's original ANDA for micafungin sodium (Micafungin), a generic echinocandin antifungal. The approval cov…
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CLINICAL_TRIALS trial_result · 2018-09-14Clinical Trial Update: Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis [Phase 3]
Phase 3 clinical trial update on anidulafungin for invasive candidiasis in children has completed with posted results.
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FDA approval · 2018-03-13FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approves a supplemental application for Cancidas (caspofungin acetate) to update labeling and/or expand its indications, as part of Merc…
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FDA approval · 2018-01-05FDA Approved: ERAXIS — Supplemental Application (Roerig)
FDA approved a supplemental application for ERAXIS (anidulafungin) submitted by Roerig to update/expand the product labeling.
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CLINICAL_TRIALS trial_result · 2017-11-30Clinical Trial Update: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
A post-marketing surveillance study assessing the safety and efficacy of Eraxis IV in candidemia and other Candida infections completed with…
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CLINICAL_TRIALS trial_result · 2017-08-01Clinical Trial Update: Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections [Phase 3]
Phase 3 trial evaluating isavuconazole (BAL8557) for candidemia and invasive candidiasis; results were posted in 2017.
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CLINICAL_TRIALS research · 2016-10-13Clinical Trial Update: A Laboratory-based Surveillance Study of Candida Bloodstream Infections (MK-0991-093)
A laboratory-based surveillance study investigating Candida bloodstream infections (Candidemia), sponsored by Merck Sharp & Dohme LLC, which…
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FDA approval · 2016-05-31FDA Approved: VORICONAZOLE — Original Application (Lupin Pharmaceuticals,Inc.)
FDA approval of Lupin's original application for a generic voriconazole product used to treat invasive fungal infections, including invasive…
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CLINICAL_TRIALS withdrawal · 2016-05-12Clinical Trial Update: Bio-assay Development and Implementation for Fungal Infection Detection
The trial evaluating a bio-assay for detecting fungal infections, focusing on candidemia, has been withdrawn.