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Pulmonary Hypertension News

Related terms: PAH, Pulmonary Arterial Hypertension

FDA Approves Winrevair for Pulmonary Arterial Hypertension in Adults

THURSDAY, March 28, 2024 – The U.S. Food and Drug Administration has approved Winrevair (sotatercept-csrk) as an injectable treatment for pulmonary arterial hypertension (PAH) in adults. The FDA...

FDA Approves Winrevair (sotatercept-csrk) a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension

RAHWAY, N.J.--(BUSINESS WIRE) March 26, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved ...

FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension

RARITAN, NJ, March 22, 2024 – Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin rece...

CMP Pharma, Inc Announces that Liqrev, the First and Only Ready-made FDA-approved Liquid Suspension of Sildenafil is Now Available

FARMVILLE, N.C., June 21, 2023/ — CMP Pharma, Inc. announced today that Liqrev (Sildenafil) Oral Suspension, 10 mg/mL, the first and only FDA-approved ready-made oral liquid of sildenafil, is now a...

United Therapeutics Announces FDA Approval of Tyvaso DPI

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE) May 24, 2022 – United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the U.S. Food...

Uptravi (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)

TITUSVILLE, N.J. – July 30, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Uptravi (selexipag) inj...

Actelion Receives FDA Approval of Tracleer (bosentan) for Use in Pediatric Patients with Pulmonary Arterial Hypertension

SOUTH SAN FRANCISCO, Calif, September 6, 2017 – Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that the U.S. Food and Drug A...

FDA Approves Uptravi (selexipag) for Pulmonary Arterial Hypertension

December 22, 2015 – On December 21, the U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and...

FDA Medwatch Alert: Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension

ISSUE: FDA is clarifying its previous recommendation related to prescribing Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH). Revatio is FDA-approved only to treat PAH in...

FDA Approves Orenitram (treprostinil) Extended-Release Tablets for the Treatment of Pulmonary Arterial Hypertension

SILVER SPRING, Md., Dec. 20, 2013 /PRNewswire/ – United Therapeutics Corporation announced today that the United States Food and Drug Administration (FDA) has approved Orenitram (treprostinil)...

FDA Approves Opsumit to Treat Pulmonary Arterial Hypertension

October 18, 2013 – The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and...

FDA Approves Adempas to Treat Pulmonary Hypertension

October 8, 2013 – The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension. Pulmonary hypertension is caused by abnormally...

FDA Medwatch Alert: Revatio (sildenafil): Drug Safety Communication - Recommendation Against Use in Children

ISSUE: FDA notified healthcare professionals and their medical care organizations that Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary arterial...

FDA Approves Intravenous Formulation Of Pfizer's Revatio (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

Revatio is the Only Treatment in Its Class with Both Oral and Intravenous Formulations NEW YORK--(BUSINESS WIRE)--Nov 20, 2009 - Pfizer announced today that the U.S. Food and Drug Administration...

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