Histoplasmosis
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-06-12EMA Authorised: Posaconazole Accord (posaconazole) — Accord Healthcare S.L.U.
Authorised status for Posaconazole Accord, MAH Accord Healthcare S.L.U., in the therapeutic area of mycoses.
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CLINICAL_TRIALS research · 2026-02-09Clinical Trial Update: Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT) [Phase 3]
Phase 3 trial update describing the Histoplasmosis Induction and Consolidation Therapy Factorial (Histo-FACT) study. The trial investigates …
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FDA approval · 2025-06-02FDA Approved: AMPHOTERICIN B — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved an original application for Amphotericin B as a generic drug by Heritage Pharmaceuticals (Avet) to treat serious systemic funga…
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CLINICAL_TRIALS trial_result · 2025-03-14Clinical Trial Update: Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients [Phase 2]
Phase 2 randomized trial results evaluate liposomal amphotericin B for histoplasmosis in patients with Acquired immune deficiency syndrome; …
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FDA approval · 2025-03-12FDA Approved: ITRACONAZOLE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for itraconazole from Ascend Laboratories, LLC, authorizing changes to the generic product under AND…
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CLINICAL_TRIALS research · 2025-02-04Clinical Trial Update: Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS [Phase 3]
Phase 3 clinical trial assessing the efficacy and safety of high-dose liposomal amphotericin B for disseminated Histoplasma capsulatum infec…
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FDA approval · 2025-01-29FDA Approved: ITRACONAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for itraconazole by Camber Pharmaceuticals, expanding/updating labeling for the generic product.
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CLINICAL_TRIALS trial_result · 2024-11-20Clinical Trial Update: Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment [Phase 3]
Phase 3 study assessing ibrexafungerp in patients with invasive and mucocutaneous fungal diseases refractory to or intolerant of standard tr…
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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 · 2024-09-03Clinical Trial Update: Prevalence of Histoplasmosis in HIV + Patients with a Rapid Diagnostic Test in West Indies
The study evaluated the prevalence of histoplasmosis among HIV-infected patients in the West Indies using a rapid diagnostic test; the trial…
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FDA approval · 2023-07-17FDA Approved: FLUCONAZOLE IN SODIUM CHLORIDE — Supplemental Application (Hospira, Inc.)
FDA approved Hospira's supplemental application for Fluconazole in Sodium Chloride, establishing an intravenous formulation of fluconazole. …
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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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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 · 2021-12-14FDA Approved: AMPHOTERICIN B — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries' original application for Amphotericin B, confirming a generic version of the antifungal. The…
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CLINICAL_TRIALS trial_result · 2021-11-04Clinical Trial Update: A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS [Phase 2]
Phase 2 trial investigating itraconazole for treatment and prevention of histoplasmosis in patients with AIDS has completed.
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FDA approval · 2019-07-16FDA Approved: FLUCONAZOLE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Fluconazole from Zydus Lifesciences Limited, resulting in regulatory approval of this generic pr…
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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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CLINICAL_TRIALS trial_result · 2016-03-04Clinical Trial Update: A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers [Phase 1]
A Phase 1 pharmacokinetic study in healthy Korean male volunteers evaluating Lozanoc and Sporanox has completed. Sponsor: Boryung Pharmaceut…
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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 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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FDA approval · 2012-01-25FDA Approved: FLUCONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for fluconazole submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2011-08-25FDA Approved: KETOCONAZOLE — Original Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved Padagis Israel Pharmaceuticals Ltd's Ketoconazole original application (ANDA 091550) for a generic ketoconazole product.
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FDA approval · 2010-03-05FDA Approved: AMPHOTERICIN B — Supplemental Application (XGen Pharmaceuticals DJB, Inc.)
FDA approved a supplemental application for Amphotericin B submitted by XGen Pharmaceuticals DJB, Inc. This approval authorizes a change to …
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CLINICAL_TRIALS trial_result · 2009-09-17Clinical Trial Update: Submacular Surgery Trials (SST) [Phase 3]
Phase 3 Submacular Surgery Trials for age-related macular degeneration and histoplasmosis have completed.
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CLINICAL_TRIALS withdrawal · 2008-08-01Clinical Trial Update: Withdrawal of Antifungal Treatment for Histoplasmosis in Patients After Improved Immune Response to Anti-HIV Drugs
This clinical trial update reports withdrawal of antifungal treatment for histoplasmosis in patients who showed improved immune response to …