Cushing Disease

• 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.

• FDA approval · 2025-04-15
  FDA Approved: ISTURISA — Supplemental Application (Recordati Rare Diseases, Inc.)

  The FDA approved a supplemental application for ISTURISA (osilodrostat) filed by Recordati Rare Diseases, Inc., reflecting an approved updat…

• EMA approval · 2024-12-18
  EMA Authorised: Signifor (pasireotide) — Recordati Rare Diseases

  The EMA authorised Signifor (pasireotide) for acromegaly and pituitary ACTH hypersecretion. Recordati Rare Diseases is the marketing authori…

• FDA approval · 2020-03-06
  FDA Approved: ISTURISA — Original Application (Recordati Rare Diseases, Inc.)

  FDA approved ISTURISA (osilodostat) through an original NDA for adults with Cushing's disease. The approval provides a new treatment option …

• FDA approval · 2019-01-29
  FDA Approved: SIGNIFOR — Supplemental Application (Recordati Rare Diseases, Inc.)

  The FDA approved a supplemental application for Signifor (pasireotide) submitted by Recordati Rare Diseases, Inc. This action expands the dr…

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• FDA approval · 2015-03-17
  FDA Approved: SIGNIFOR — Supplemental Application (Recordati Rare Diseases, Inc.)

  The FDA approved a supplemental application for Signifor (pasireotide) filed by Recordati Rare Diseases, Inc., potentially expanding its lab…

• FDA approval · 2014-12-15
  FDA Approved: SIGNIFOR LAR — Original Application (Recordati Rare Diseases, Inc.)

  The FDA granted original approval for Signifor LAR (pasireotide) from Recordati Rare Diseases, Inc. for the treatment of adults with Cushing…

• EMA approval · 2012-01-20
  European Medicines Agency recommends approval of new medicine for Cushing's disease

  EMA recommends approval of a new medicine for Cushing's disease, indicating a potential new treatment option after evaluation.