Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA approval · 2018-10-23FDA Approved: FLOLAN — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for FLOLAN (epoprostenol sodium) from GlaxoSmithKline LLC, reflecting an approved change to the …
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CLINICAL_TRIALS trial_result · 2018-10-22Clinical Trial Update: Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003) [Phase 1]
Phase 1 trial update for acute dosing of MK-8892 in participants with pulmonary arterial hypertension (PAH) has been terminated; results pos…
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FDA approval · 2018-10-16FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc.
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CLINICAL_TRIALS trial_result · 2018-09-26Clinical Trial Update: Comparative PK PD Study in PAH Patients (Fox vs. I-Neb) [Phase 1, Phase 2]
A comparative PK/PD study in pulmonary arterial hypertension patients comparing Fox with I-Neb across Phase 1 and Phase 2 is completed.
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CLINICAL_TRIALS trial_result · 2018-09-24Clinical Trial Update: Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH [Phase 2]
A Phase 2 clinical trial assessing the impact of inhaled nitric oxide on invasively derived pulmonary pressures in patients with pulmonary a…
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CLINICAL_TRIALS trial_result · 2018-08-22Clinical Trial Update: Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument [Phase 3]
Phase 3 trial update for macitentan in pulmonary arterial hypertension focusing on psychometric validation of the PAH-SYMPACT instrument; st…
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CLINICAL_TRIALS trial_result · 2018-08-17Clinical Trial Update: Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients [Phase 1]
Phase 1 PET biodistribution study evaluating [11C]-GSK2256098 in healthy subjects and pulmonary arterial hypertension patients; completed wi…
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FDA approval · 2018-07-30FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for REMODULIN (treprostinil) by United Therapeutics Corporation.
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CLINICAL_TRIALS withdrawal · 2018-07-09Clinical Trial Update: Tezosentan in Pulmonary Arterial Hypertension [Phase 2]
A Phase 2 trial of tezosentan for pulmonary arterial hypertension was terminated.
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CLINICAL_TRIALS trial_result · 2018-07-09Clinical Trial Update: Tezosentan in Patients With Pulmonary Arterial Hypertension [Phase 2]
A Phase 2 trial of tezosentan for pulmonary arterial hypertension was terminated.
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FDA approval · 2018-06-27FDA Approved: SILDENAFIL — Original Application (Amneal Pharmaceuticals NY LLC)
The FDA approved Amneal Pharmaceuticals NY LLC's original application for sildenafil, enabling a generic sildenafil product under ANDA 20202…
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CLINICAL_TRIALS research · 2018-06-26Clinical Trial Update: Surgical Valvuloplasty for Congenital Mitral Insufficiency
Clinical trial update on surgical valvuloplasty for congenital mitral insufficiency; the trial status is currently unknown.
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CLINICAL_TRIALS trial_result · 2018-06-12Clinical Trial Update: First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension
The document reports on a completed clinical trial evaluating first-line combination therapy with bosentan and sildenafil for pulmonary arte…
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FDA approval · 2018-06-11FDA Approved: SILDENAFIL — Original Application (XLCARE Pharmaceuticals INC.)
FDA approved sildenafil as a generic drug under an Original Application (ANDA 202659) for XLCARE Pharmaceuticals Inc.
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FDA approval · 2018-06-11FDA Approved: SILDENAFIL — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for sildenafil, granting a generic version of the erectile dysfunction drug to Aurobindo Pharma Limite…
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FDA approval · 2018-06-11FDA Approved: SILDENAFIL — Original Application (Advagen Pharma Ltd)
FDA approved a sildenafil generic from Advagen Pharma Ltd under Original Application, enabling a generic version with the established indica…
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FDA approval · 2018-06-08FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for REMODULIN (treprostinil) submitted by United Therapeutics Corporation. The action approves t…
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CLINICAL_TRIALS research · 2018-05-23Clinical Trial Update: Imaging Control Study, 3D Echo, MR and RHC.
An update on an imaging control study using 3D echocardiography, magnetic resonance imaging, and right heart catheterization in patients wit…
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CLINICAL_TRIALS research · 2018-05-23Clinical Trial Update: 3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH
Clinical trial update describing a 3D echocardiography evaluation of the ventricles in severe pulmonary arterial hypertension.
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FDA approval · 2018-05-14FDA Approved: FLOLAN — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for FLOLAN (epoprostenol sodium) from GlaxoSmithKline LLC.
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CLINICAL_TRIALS trial_result · 2018-05-14Clinical Trial Update: Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension [NA]
This clinical trial update reports a completed study examining right ventricular–pulmonary vascular interactions in pulmonary arterial hyper…
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CLINICAL_TRIALS trial_result · 2018-05-04Clinical Trial Update: DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study [NA]
Update on Medtronic's DelIVery trial for pulmonary arterial hypertension (PAH); the study is currently active but not recruiting, with resul…
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CLINICAL_TRIALS withdrawal · 2018-05-01Clinical Trial Update: Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil [Phase 4]
Phase 4 trial evaluating sildenafil for pulmonary hypertension associated with idiopathic pulmonary fibrosis was withdrawn.
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CLINICAL_TRIALS trial_result · 2018-04-19Clinical Trial Update: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension [Phase 2]
Open-label Phase 2 trial evaluating tocilizumab for pulmonary arterial hypertension has completed.
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FDA approval · 2018-04-18FDA Approved: TREPROSTINIL — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz Inc for TREPROSTINIL, adding a water solution formulation of treprostinil.