Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2021-05-06Clinical Trial Update: Angiogenic Imaging in Pulmonary Arterial Hypertension [Phase 1, Phase 2]
Phase 1 and Phase 2 clinical trial update on angiogenic imaging in patients with pulmonary arterial hypertension, completed.
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FDA approval · 2021-03-31FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)
FDA approved a supplemental application for TYVASO (treprostinil) from United Therapeutics Corporation. This approval updates the product la…
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FDA approval · 2021-03-17FDA Approved: TADALAFIL — Supplemental Application (Cipla USA Inc.)
The FDA approved a supplemental application for tadalafil from Cipla USA Inc. under ANDA210255, expanding the approved generic product for a…
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CLINICAL_TRIALS trial_result · 2021-03-16Clinical Trial Update: Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH
Clinical trial update reporting results for patient global impression questions addressing activity-induced symptoms in participants with pu…
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CLINICAL_TRIALS trial_result · 2021-02-23Clinical Trial Update: Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension. [Phase 4]
Phase 4 trial evaluating the effect of selexipag on daily life physical activity in patients with pulmonary arterial hypertension; results w…
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FDA approval · 2021-02-11FDA Approved: TREPROSTINIL — Original Application (Alembic Pharmaceuticals Inc.)
The FDA approved Alembic Pharmaceuticals' original ANDA for treprostinil, enabling the generic version of the drug to be marketed.
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CLINICAL_TRIALS trial_result · 2021-02-01Clinical Trial Update: A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension [Phase 3]
A Phase 3 study evaluating 20, 40, and 80 mg of sildenafil taken three times daily for pulmonary arterial hypertension has completed.
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CLINICAL_TRIALS trial_result · 2021-02-01Clinical Trial Update: Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension [Phase 3]
A Phase 3 study assessing long-term safety of sildenafil citrate in patients with pulmonary arterial hypertension has completed.
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FDA label_change · 2021-01-30FDA Approved: UPTRAVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for Uptravi (selexipag) to update the labeling; Uptravi is used for pulmonary arterial hypertension …
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CLINICAL_TRIALS trial_result · 2021-01-22Clinical Trial Update: Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy [Phase 4]
Phase 4 trial comparing riociguat to PDE-5 inhibitor therapy in pulmonary arterial hypertension has completed with results posted.
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FDA approval · 2021-01-15FDA Approved: EPOPROSTENOL — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved the original ANDA for epoprostenol from Sun Pharmaceutical Industries, Inc., confirming a generic version of the pulmonary arte…
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FDA approval · 2021-01-07FDA Approved: TADALAFIL — Supplemental Application (HEC Pharm USA Inc.)
The FDA approved a supplemental application for tadalafil from HEC Pharm USA Inc., indicating approval of an additional generic tadalafil pr…
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FDA approval · 2020-12-22FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for LETAIRIS (ambrisentan) from Gilead Sciences, Inc.
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for ambrisentan (Actavis Pharma, Inc.) under ANDA208252.
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Ambrisentan from Sun Pharmaceutical Industries, Inc.
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Sigmapharm Laboratories, LLC)
FDA approved a supplemental application to authorize a generic version of Ambrisentan by Sigmapharm Laboratories, LLC (ANDA 208354).
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)
FDA records a supplemental approval application for ambrisentan submitted by Cipla USA Inc., potentially updating the drug's approval or lab…
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for ambrisentan from Mylan Pharmaceuticals Inc., enabling the generic ambrisentan product under …
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental ANDA from Zydus Lifesciences Limited for ambrisentan, authorizing a generic version for pulmonary arterial hyper…
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FDA approval · 2020-11-30FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for ADEMPAS (riociguat) filed by Bayer HealthCare Pharmaceuticals Inc.
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FDA approval · 2020-11-03FDA Approved: ORENITRAM — Supplemental Application (United Therapeutics Corporation)
FDA approved a supplemental application for ORENITRAM (treprostinil) submitted by United Therapeutics Corporation.
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FDA approval · 2020-10-27FDA Approved: N/A — Original Application (Bostal LLC)
FDA approved an original application for tadalafil (generic) by Bostal LLC under ANDA 208824.
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CLINICAL_TRIALS trial_result · 2020-10-22Clinical Trial Update: BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension [Phase 3]
Phase 3 long-term extension study of BAY63-2521 in patients with pulmonary arterial hypertension has completed with results posted.
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FDA label_change · 2020-10-21FDA Approved: VELETRI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for VELETRI (epoprostenol) from Actelion Pharmaceuticals US, Inc., resulting in an update to the…
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CLINICAL_TRIALS trial_result · 2020-10-20Clinical Trial Update: Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH) [Phase 2]
Phase 2 compassionate use trial update for beraprost sodium 314d modified release in pulmonary arterial hypertension has completed.