Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-02-21FDA Approved: TADALAFIL — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for tadalafil submitted by Dr.Reddys Laboratories Inc.
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FDA approval · 2020-02-14FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for ambrisentan from Cipla USA Inc., indicating approval of a supplemental filing for the generic dr…
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FDA approval · 2020-02-14FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)
This entry documents a supplemental application for ambrisentan submitted by Zydus Lifesciences Limited to the FDA.
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CLINICAL_TRIALS trial_result · 2020-02-13Clinical Trial Update: Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy [Phase 3]
Phase III trial update for UT-15C in pulmonary arterial hypertension; study completed with results posted in 2020.
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FDA approval · 2020-02-10FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for ADEMPAS (riociguat) submitted by Bayer HealthCare Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2020-02-05Clinical Trial Update: Effect of Pharmacologic Interaction Between ERAs and PDE-5 Inhibitors on Medication Serum Levels and Clinical Disease Status in Patients With PAH
A completed clinical trial evaluated how pharmacologic interactions between ERA therapies and PDE-5 inhibitors affect drug serum levels and …
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CLINICAL_TRIALS withdrawal · 2020-01-29Clinical Trial Update: Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial Hypertension [Phase 3]
Phase 3 trial investigating a bronchodilator for exertional dyspnea in pulmonary arterial hypertension was withdrawn.
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FDA approval · 2020-01-15FDA Approved: SILDENAFIL — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for sildenafil from Amneal Pharmaceuticals of New York LLC to market a generic sildenafil produc…
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CLINICAL_TRIALS trial_result · 2019-12-26Clinical Trial Update: An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients [Phase 2]
Open-label extension study of BPS-MR-PAH-201 in pulmonary arterial hypertension completed with results posted.
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FDA approval · 2019-12-09FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for ambrisentan filed by Zydus Lifesciences Limited under the ANDA framework.
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CLINICAL_TRIALS trial_result · 2019-12-09Clinical Trial Update: Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension [Phase 2]
Phase 2 clinical trial evaluating an estrogen receptor antagonist in patients with pulmonary arterial hypertension has completed with posted…
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FDA approval · 2019-11-27FDA Approved: SILDENAFIL — Original Application (Ajanta Pharma USA Inc.)
FDA approves Ajanta Pharma USA Inc.'s original application for sildenafil (generic) for use in erectile dysfunction and pulmonary arterial h…
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CLINICAL_TRIALS trial_result · 2019-11-15Clinical Trial Update: The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study [Phase 4]
Phase 4 trial investigating ambrisentan in combination with spironolactone for pulmonary arterial hypertension has been terminated with resu…
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FDA approval · 2019-11-06FDA Approved: AMBRISENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' supplemental application for AMBRISENTAN (ambrisentan), authorizing the generic version's approv…
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FDA approval · 2019-11-06FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)
The FDA approved a supplemental application for ambrisentan from Cipla USA Inc., authorizing a supplemental approval under ANDA210715.
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FDA approval · 2019-11-06FDA Approved: AMBRISENTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for a generic ambrisentan from Mylan Pharmaceuticals.
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FDA label_change · 2019-11-04FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA supplemental approval for bosentan by Actavis Pharma, Inc. resulting in changes to the product labeling.
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FDA approval · 2019-11-01FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Bosentan from Zydus Pharmaceuticals USA Inc., authorizing a generic bosentan product for pulmona…
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FDA approval · 2019-10-18FDA Approved: ORENITRAM — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for ORENITRAM (treprostinil) submitted by United Therapeutics Corporation. The action updates th…
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CLINICAL_TRIALS trial_result · 2019-10-08Clinical Trial Update: Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA) [Phase 4]
Phase 4 clinical trial evaluating first-line combination therapy of macitentan and tadalafil in newly diagnosed pulmonary arterial hypertens…
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CLINICAL_TRIALS trial_result · 2019-10-07Clinical Trial Update: Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial [Phase 2]
A Phase 2 clinical trial evaluating fluoxetine for pulmonary arterial hypertension has completed with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-10-03Clinical Trial Update: The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension [Phase 2, Phase 3]
A clinical trial evaluating trimetazidine for right ventricular function in precapillary pulmonary hypertension has completed Phase 2 and Ph…
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FDA approval · 2019-09-26FDA Approved: TREPROSTINIL — Original Application (Teva Parenteral Medicines, Inc.)
FDA approved Teva Parenteral Medicines’ TREPROSTINIL as an Original Application, confirming a generic treprostinil product for pulmonary art…
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CLINICAL_TRIALS trial_result · 2019-09-16Clinical Trial Update: Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients [Phase 2]
A Phase 2 extension study update for BPS-MR-PAH-203 in patients with pulmonary arterial hypertension (PAH).
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FDA approval · 2019-09-04FDA Approved: UPTRAVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for UPTRAVI (selexipag) submitted by Actelion Pharmaceuticals US, Inc.