Candidiasis
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Sign up freeTop drugs studied for this disease
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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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FDA approval · 2025-04-25FDA Approved: FLUCONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for fluconazole by Hikma Pharmaceuticals USA Inc., advancing the approval of this generic antifu…
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CLINICAL_TRIALS trial_result · 2025-04-02Clinical Trial Update: Prospective Observational Study on the Incidence of Opportunistic Fungal Infections
Completed prospective observational study assessing the incidence of opportunistic fungal infections, including Pneumocystis jirovecii pneum…
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FDA approval · 2025-03-21FDA Approved: NYSTATIN — Original Application (Aurobindo Pharma Limited)
FDA approved a generic Nystatin product from Aurobindo Pharma Limited under an Original Application.
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FDA approval · 2025-03-13FDA Approved: POSACONAZOLE — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for posaconazole from Mylan Institutional LLC, updating the approval for the generic product.
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EMA approval · 2025-01-21EMA Authorised: Posaconazole AHCL (posaconazole) — Accord Healthcare S.L.U.
EMA authorised Posaconazole AHCL by Accord Healthcare S.L.U. for mycoses. The EU marketing authorization was granted on 16 January 2025.
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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: POSACONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for posaconazole (POSACONAZOLE), approving the generic product.
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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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FDA approval · 2024-09-16FDA Approved: KETOCONAZOLE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' original application for a generic ketoconazole product.
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CLINICAL_TRIALS trial_result · 2024-08-27Clinical Trial Update: Non-ablative Er:YAG for Recurrent Candidiasis [NA]
This update reports the completion of a clinical trial evaluating non-ablative Er:YAG treatment for recurrent vulvovaginal candidiasis. The …
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CLINICAL_TRIALS safety_alert · 2024-07-17Clinical Trial Update: Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
This clinical trial update discusses safety data collection for pregnant subjects exposed to ibrefungerp and potential infant outcomes. The …
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FDA approval · 2024-06-25FDA Approved: FLUCONAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for Fluconazole from Dr. Reddy's Laboratories Limited (ANDA 076658).
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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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EMA withdrawal · 2023-10-23EMA Application withdrawn: Vivjoa (oteseconazole) — Gedeon Richter Plc.
The EMA has withdrawn the application for Vivjoa (oteseconazole) by Gedeon Richter Plc. for candidiasis.
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FDA approval · 2023-08-08FDA 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…
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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 · 2023-07-14FDA 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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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 · 2022-12-08FDA 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…
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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 · 2022-08-16FDA Approved: VORICONAZOLE — Supplemental Application (Xellia Pharmaceuticals USA LLC)
FDA approved a supplemental application for Voriconazole by Xellia Pharmaceuticals USA LLC.
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FDA approval · 2022-07-28FDA Approved: POSACONAZOLE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for posaconazole delayed-release (POSACONAZOLE DELAYED-RELEASE) from Chartwell RX, LLC, updating its…
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FDA approval · 2022-05-25FDA Approved: POSACONAZOLE — Original Application (Par Health USA, LLC)
FDA approved the original application for posaconazole (generic) by Par Health USA, LLC, marking the availability of a generic posaconazole …
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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.