Cryptococcal Meningitis

• CLINICAL_TRIALS research · 2026-04-24
  Clinical Trial Update: Fungal Infection Susceptibility

  This clinical trial update from NIAID reports ongoing recruitment to study susceptibility to fungal infections caused by Cryptococcus. The c…

• CLINICAL_TRIALS research · 2026-04-20
  Clinical Trial Update: Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia

  This clinical trial registry entry describes a study on the etiology, pathogenesis, and natural history of idiopathic CD4+ lymphocytopenia. …

• FDA approval · 2026-01-14
  FDA Approved: FLUCONAZOLE IN SODIUM CHLORIDE — Supplemental Application (Hospira, Inc.)

  The FDA approved Hospira's supplemental application for Fluconazole in Sodium Chloride (intravenous formulation), adding this generic IV flu…

• CLINICAL_TRIALS research · 2026-01-07
  Clinical Trial Update: Platform Trial For Cryptococcal Meningitis [Phase 2, Phase 3]

  A platform clinical trial for cryptococcal meningitis in people with HIV is currently recruiting and will run through Phase 2 and Phase 3.

• CLINICAL_TRIALS trial_result · 2025-08-27
  Clinical Trial Update: Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis [Phase 2]

  Phase 2 trial results report on optimizing the dosing of flucytosine for cryptococcal meningitis, with results posted after completion. The …

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• FDA approval · 2025-04-25
  FDA 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…

• FDA approval · 2024-06-25
  FDA Approved: FLUCONAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Fluconazole from Dr. Reddy's Laboratories Limited (ANDA 076658).

• CLINICAL_TRIALS trial_result · 2023-12-21
  Clinical Trial Update: Amphotericin B for Non-HIV Cryptococcal Meningitis Patients [Phase 4]

  Phase 4 trial update for Amphotericin B in non-HIV cryptococcal meningitis is currently enrolling by invitation.

• FDA approval · 2023-10-24
  FDA Approved: FLUCONAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approves a supplemental application for fluconazole submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2023-07-14
  FDA 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…

• CLINICAL_TRIALS trial_result · 2023-04-12
  Clinical Trial Update: Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia [Phase 2, Phase 3]

  Phase 2/3 clinical trial update evaluating single-dose liposomal amphotericin for asymptomatic cryptococcal antigenemia related to cryptococ…

• CLINICAL_TRIALS trial_result · 2023-03-31
  Clinical Trial Update: Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) [Phase 1, Phase 2]

  Clinical trial update for Encochleated oral amphotericin for cryptococcal meningitis (EnACT) in Phase 1 and Phase 2, with completed status.

• FDA approval · 2023-03-17
  FDA 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…

• FDA approval · 2022-11-17
  FDA 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.

• CLINICAL_TRIALS trial_result · 2022-09-15
  Clinical Trial Update: Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3 [Phase 3]

  A Phase 3 clinical trial evaluating encochleated oral amphotericin for cryptococcal meningitis is ongoing, with status currently unknown.

• FDA approval · 2021-12-14
  FDA 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…

• CLINICAL_TRIALS trial_result · 2021-10-28
  Clinical Trial Update: Dexamethasone in Cryptococcal Meningitis [Phase 2]

  Phase 2 trial update on dexamethasone for cryptococcal meningitis, completed.

• FDA approval · 2021-10-25
  FDA Approved: DIFLUCAN — Supplemental Application (Roerig)

  The FDA approved a supplemental application for Diflucan (fluconazole) submitted by Roerig.

• FDA approval · 2021-10-06
  FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for fluconazole from Rising Pharma Holdings, Inc., related to this generic antifungal product.

• FDA approval · 2020-06-22
  FDA Approved: FLUCONAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for fluconazole submitted by Chartwell RX, LLC.

• CLINICAL_TRIALS research · 2020-06-04
  Clinical Trial Update: Operational Research for Cryptococcal Antigen Screening [Phase 4]

  Phase 4 operational research trial update on cryptococcal antigen screening, completed.

• CLINICAL_TRIALS trial_result · 2020-01-13
  Clinical Trial Update: Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis [Phase 3]

  Phase 3 trial evaluating adjunctive sertraline for HIV-associated cryptococcal meningitis has completed with results posted.

• CLINICAL_TRIALS trial_result · 2019-12-02
  Clinical Trial Update: Treatment With Tamoxifen in Cryptococcal Meningitis [Phase 2]

  A Phase 2 clinical trial evaluating tamoxifen for treatment of cryptococcal meningitis has been completed.

• CLINICAL_TRIALS trial_result · 2019-10-29
  Clinical Trial Update: AmB Dose for Cryptococcal Meningitis [Phase 3]

  Phase 3 trial update examining AmB dose for cryptococcal meningitis; status is currently unknown.

• FDA approval · 2019-07-16
  FDA 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…