Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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EMA approval · 2025-12-19EMA Authorised: Macitentan Accord (macitentan) — Accord Healthcare
The EMA authorised Macitentan Accord for treatment of pulmonary arterial hypertension; the marketing authorisation holder is Accord Healthca…
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EMA approval · 2025-12-19EMA Authorised: Macitentan AccordPharma (macitentan) — Accord Healthcare
The EMA authorised Macitentan AccordPharma (macitentan) for the treatment of pulmonary hypertension, including pulmonary arterial hypertensi…
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EMA approval · 2025-12-16EMA Authorised: Ambrisentan Viatris (previously Ambrisentan Mylan) (ambrisentan) — Viatris Limited
The EMA authorised Ambrisentan Viatris (ambrisentan) for pulmonary arterial hypertension, with Viatris Limited as the marketing authorisatio…
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EMA approval · 2025-12-16EMA Authorised: Ventavis (iloprost) — Bayer AG
The European Medicines Agency authorised Ventavis (iloprost) by Bayer AG for pulmonary arterial hypertension, marking formal EU marketing ap…
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EMA approval · 2025-12-03EMA Authorised: Adempas (riociguat) — Bayer AG
EMA authorised Adempas (riociguat) by Bayer AG for pulmonary hypertension indications, with a decision dated 06/08/2025.
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EMA approval · 2025-12-02EMA Authorised: Mysildecard (sildenafil) — Viatris Limited
The European Medicines Agency authorised Mysildecard (sildenafil) for indications related to hypertension and pulmonary hypertension, with V…
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FDA approval · 2025-11-05FDA 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.
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FDA approval · 2025-11-05FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for bosentan submitted by Actavis Pharma, Inc.
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FDA approval · 2025-11-05FDA Approved: BOSENTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for a generic bosentan (ANDA213154).
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FDA approval · 2025-11-05FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved Zydus Pharmaceuticals USA Inc.'s supplemental application for Bosentan, authorizing a generic version of the drug in the U.…
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FDA approval · 2025-11-05FDA Approved: BOSENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries' supplemental application for bosentan, enabling the generic bosentan product to proceed.
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FDA approval · 2025-09-19FDA Approved: AMBRISENTAN — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application for ambrisentan from Apotex Corp., resulting in an approved update to its labeling under the exi…
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EMA approval · 2025-09-17EMA Authorised: Revatio (sildenafil) — Upjohn EESV
EMA authorised Revatio (sildenafil) for use in hypertension and pulmonary arterial hypertension, with Upjohn EESV as the marketing authoriza…
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FDA approval · 2025-08-20FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for AMBRISENTAN (ambrisentan) from Zydus Lifesciences Limited.
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FDA approval · 2025-08-20FDA Approved: MACITENTAN — Original Application (Sandoz Inc)
FDA approved a generic macitentan from Sandoz Inc through an original application for the treatment of pulmonary arterial hypertension.
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EMA approval · 2025-07-31EMA Authorised: Trepulmix (treprostinil sodium) — SciPharm Sàrl
The European Medicines Agency authorised Trepulmix (treprostinil sodium) for the treatment of pulmonary arterial hypertension and it carries…
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FDA approval · 2025-07-30FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for TRACLEER (bosentan) from Actelion Pharmaceuticals US, updating the product’s label.
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FDA approval · 2025-07-30FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for Tracleer (bosentan) by Actelion Pharmaceuticals US, Inc. The action affects its use in pulmo…
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FDA approval · 2025-07-25FDA Approved: AMBRISENTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for ambrisentan from Mylan Pharmaceuticals Inc., signaling regulatory approval related to this gener…
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FDA approval · 2025-07-18FDA Approved: AMBRISENTAN — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Ambrisentan by Aurobindo Pharma Limited, authorizing a generic version of the drug.
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FDA approval · 2025-06-30FDA Approved: SILDENAFIL — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for sildenafil (generic) from Macleods Pharmaceuticals Limited, authorizing the marketing of a gener…
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FDA approval · 2025-06-03FDA Approved: EPOPROSTENOL — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a supplemental application for epoprostenol submitted by Sun Pharmaceutical Industries, Inc., under the ANDA. The action update…
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FDA approval · 2025-05-23FDA Approved: YUTREPIA — Original Application (Liquidia Technologies, Inc.)
FDA approved YUTREPIA (treprostinil) from Liquidia Technologies as an original application for the treatment of pulmonary arterial hypertens…
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FDA approval · 2025-04-04FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for LETAIRIS (ambrisentan) from Gilead Sciences, Inc. The approval covers an updated labeling/new in…
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FDA approval · 2025-04-04FDA Approved: AMBRISENTAN — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for ambrisentan from Apotex Corp., authorizing a generic version of the drug. Ambrisentan is used to…