Systemic Sclerosis

• EMA approval · 2026-01-06
  EMA Authorised: Ofev (nintedanib) — Boehringer Ingelheim International GmbH

  The European Medicines Agency authorised a label expansion for Ofev (nintedanib) to cover additional interstitial lung diseases, including s…

• FDA approval · 2025-11-05
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  The FDA approved a supplemental application for Tracleer (bosentan) submitted by Actelion, resulting in an update to the product's labeling.

• FDA approval · 2025-11-05
  FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for bosentan submitted by Actavis Pharma, Inc.

• EMA approval · 2025-08-29
  EMA Authorised: Nintedanib Accord (nintedanib) — Accord Healthcare S.L.U.

  The EMA authorised Nintedanib Accord for indications including Idiopathic Pulmonary Fibrosis, interstitial lung diseases, systemic sclerosis…

• EMA approval · 2024-10-25
  EMA Authorised: Tracleer (bosentan (as monohydrate)) — Janssen-Cilag International N.V.

  The European Medicines Agency authorised Tracleer (bosentan) for systemic sclerosis and for pulmonary arterial hypertension.

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• EMA approval · 2024-10-24
  EMA Authorised: Stayveer (bosentan (as monohydrate)) — Janssen-Cilag International NV

  The EMA authorised Stayveer (bosentan) for use in pulmonary arterial hypertension and systemic sclerosis (scleroderma) in the European Union…

• FDA approval · 2023-06-06
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  The FDA approved a supplemental application for TRACLEER (bosentan) submitted by Actelion Pharmaceuticals US, Inc. This action updates the a…

• FDA approval · 2021-07-29
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  The FDA approved a supplemental application for TRACLEER (bosentan) from Actelion Pharmaceuticals US, Inc., resulting in labeling changes.

• FDA approval · 2018-10-25
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for Tracleer (bosentan) submitted by Actelion Pharmaceuticals US, Inc.

• FDA approval · 2017-10-20
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for Tracleer (bosentan) from Actelion Pharmaceuticals US, expanding its regulatory approval. The act…

• FDA approval · 2013-07-01
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  The FDA approved a supplemental NDA for Tracleer (bosentan) submitted by Actelion Pharmaceuticals US, Inc.

• FDA approval · 2007-06-01
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for TRACLEER (bosentan) filed by Actelion Pharmaceuticals US, Inc.