Cushing Syndrome

• FDA approval · 2025-11-04
  FDA Approved: ISTURISA — Supplemental Application (Recordati Rare Diseases, Inc.)

  The FDA approved a supplemental application for Isturisa (osilodostat) submitted by Recordati Rare Diseases, Inc.

• EMA approval · 2025-05-05
  EMA Authorised: Ketoconazole Esteve (previously Ketoconazole HRA) (Ketoconazole) — Esteve Pharmaceuticals, S.A.

  The EMA has authorised Ketoconazole Esteve for the treatment of Cushing syndrome.

• EMA approval · 2024-12-12
  EMA Authorised: Isturisa (osilodrostat phosphate) — Recordati Rare Diseases

  The European Medicines Agency authorised Isturisa (osilodrostat) for the treatment of Cushing syndrome, with Recordati Rare Diseases as the …

• FDA approval · 2023-08-16
  FDA Approved: RECORLEV — Supplemental Application (Xeris Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for RECORLEV (levoketoconazole) submitted by Xeris Pharmaceuticals, Inc.

• FDA approval · 2023-01-03
  FDA Approved: MIFEPRISTONE — Supplemental Application (GenBioPro, Inc.)

  The FDA approved GenBioPro, Inc.'s supplemental application for Mifepristone, resulting in updated labeling.

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• FDA approval · 2021-12-30
  FDA Approved: RECORLEV — Original Application (Xeris Pharmaceuticals, Inc.)

  FDA approved Recorlev (levoketoconazole) by Xeris Pharmaceuticals as an original approval for the treatment of adults with endogenous Cushin…

• FDA approval · 2021-05-14
  FDA Approved: MIFEPRISTONE — Supplemental Application (GenBioPro, Inc.)

  FDA approved GenBioPro, Inc.'s supplemental application for mifepristone, confirming its continued availability for established indications …

• FDA approval · 2020-02-20
  FDA Approved: METOPIRONE — Supplemental Application (HRA Pharma Rare Diseases)

  FDA approved a supplemental application for METOPIRONE (metyrapone) submitted by HRA Pharma Rare Diseases, resulting in an updated indicatio…

• FDA approval · 2019-11-05
  FDA Approved: MIFEPRISTONE — Supplemental Application (Corcept Therapeutics Incorporated)

  The FDA approved a supplemental application for mifepristone submitted by Corcept Therapeutics Incorporated.

• EMA approval · 2014-09-26
  Ketoconazole HRA recommended for approval in Cushing's syndrome

  The EMA recommends granting marketing authorization for ketoconazole hydrochloride (HRA) for the treatment of Cushing's syndrome, based on i…

• FDA approval · 2012-02-17
  FDA Approved: MIFEPRISTONE — Original Application (Corcept Therapeutics Incorporated)

  The FDA approved mifepristone (brand name Korlym) under an original application from Corcept Therapeutics. It is approved for adults with hy…