Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2023-01-18Clinical Trial Update: Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) [Phase 2]
Open-label extension study of ubenimex in pulmonary arterial hypertension (WHO Group 1) completed; results posted in 2023.
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CLINICAL_TRIALS trial_result · 2022-12-30Clinical Trial Update: Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529 [Phase 2]
Phase 2 pediatric long-term extension study of ambrisentan for hypertension/pulmonary hypertension completed; results posted.
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FDA approval · 2022-12-21FDA Approved: SELEXIPAG — Original Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved the original ANDA for Selexipag from Zydus Pharmaceuticals (USA) Inc., providing a generic option for treating pulmonary arteri…
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CLINICAL_TRIALS trial_result · 2022-12-15Clinical Trial Update: Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension [Phase 4]
Phase 4 trial evaluating the effects of treprostinil on right ventricular structure and function in patients with pulmonary arterial hyperte…
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FDA approval · 2022-10-12FDA Approved: ALYQ — Original Application (Teva Pharmaceuticals, Inc.)
The FDA approved ALYQ as Teva's generic tadalafil in an original ANDA approval. The approval covers the same indications as tadalafil, inclu…
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CLINICAL_TRIALS trial_result · 2022-09-19Clinical Trial Update: ACT-293987 in Pulmonary Arterial Hypertension [Phase 3]
Phase 3 trial of ACT-293987 in Pulmonary Arterial Hypertension has completed with results posted.
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CLINICAL_TRIALS trial_result · 2022-09-08Clinical Trial Update: Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery [Phase 2]
Phase 2 trial update evaluating sitaxsentan dosing in patients undergoing cardiac surgery, including CABG or cardiac valve replacement; stud…
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CLINICAL_TRIALS trial_result · 2022-08-05Clinical Trial Update: Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension [Phase 4]
A Phase 4 clinical trial evaluating management strategies for acute pulmonary hypertensive crisis in children with known pulmonary arterial …
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FDA approval · 2022-07-21FDA Approved: AMBRISENTAN — Original Application (Aurobindo Pharma Limited)
FDA approved the Original Application for ambrisentan as a generic version by Aurobindo Pharma Limited. The drug is used for the treatment o…
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FDA approval · 2022-07-07FDA Approved: STERILE DILUENT FOR TREPROSTINIL — Supplemental Application (Dr.Reddy's Laboratories Inc.,)
FDA approved a supplemental application for a sterile diluent for Treprostinil, submitted by Dr. Reddy's Laboratories Inc.
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CLINICAL_TRIALS trial_result · 2022-06-29Clinical Trial Update: Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension [Phase 3]
A Phase 3 trial updating efficacy and safety of ambrisentan in Chinese patients with pulmonary arterial hypertension has completed.
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CLINICAL_TRIALS trial_result · 2022-06-02Clinical Trial Update: An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension [Phase 3]
An open-label, long-term Phase 3 study evaluating oral treprostinil in subjects with pulmonary arterial hypertension has completed with resu…
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FDA approval · 2022-05-27FDA Approved: TADALAFIL — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Tadalafil submitted by Aurobindo Pharma Limited. This action adds regulatory approval for th…
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FDA approval · 2022-05-23FDA Approved: TYVASO DPI — Original Application (United Therapeutics Corporation)
FDA approves TYVASO DPI as an Original Application, introducing a dry powder inhalation formulation of treprostinil from United Therapeutics…
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FDA approval · 2022-05-20FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for TYVASO (treprostinil) submitted by United Therapeutics Corporation.
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FDA approval · 2022-05-19FDA Approved: AMBRISENTAN — Original Application (Apotex Corp.)
FDA approves Apotex Corp.'s original application for ambrisentan, a generic form of the pulmonary arterial hypertension treatment.
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FDA approval · 2022-05-18FDA Approved: TADALAFIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for tadalafil from Quallent Pharmaceuticals Health LLC. This action concerns the approval of a g…
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CLINICAL_TRIALS trial_result · 2022-05-10Clinical Trial Update: Effects of Oral Sildenafil on Mortality in Adults With PAH [Phase 4]
Phase 4 trial evaluating the effects of oral sildenafil on mortality in adults with pulmonary arterial hypertension has been terminated; res…
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FDA label_change · 2022-04-29FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a Supplemental Application for TRACLEER (bosentan) to update the drug’s labeling.
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FDA approval · 2022-04-29FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Bosentan from Zydus Pharmaceuticals USA Inc., enabling a generic version of Bosentan to be m…
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FDA approval · 2022-04-29FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for sildenafil citrate submitted by Ascend Laboratories, LLC, resulting in approval of a generic…
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FDA approval · 2022-04-29FDA Approved: BOSENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Bosentan submitted by Sun Pharmaceutical Industries, Inc. This approval expands the drug's label…
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FDA approval · 2022-04-29FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for bosentan from Actavis Pharma, enabling a generic version of bosentan to be marketed. This approv…
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CLINICAL_TRIALS trial_result · 2022-03-17Clinical Trial Update: Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension [Phase 1]
Phase 1 trial of dimethyl fumarate in systemic sclerosis-associated pulmonary arterial hypertension has been terminated; results posted.
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CLINICAL_TRIALS trial_result · 2022-03-07Clinical Trial Update: IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients [Phase 2]
Phase 2 trial evaluating IV iron replacement for iron deficiency in idiopathic pulmonary arterial hypertension completed with results posted…