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FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension

The US Food and Drug Administration (FDA) has granted approval for Johnson & Johnson's (J&J) OPSYNVI for chronic treatment of adult patients with pulmonary arterial hypertension (PAH), World Health ... read more

With Merck's key PAH approval on tap, Johnson & Johnson wins nod for combo tablet

The FDA has signed off on Opsynvi, a tablet which combines J&J’s Opsumit (macitanten) and United Therapeutics' Adcirca (tadalafil) which are commonly prescribed together to treat the condition. read more

FDA approves first-in-class drug for rare lung disorder

The US Food and Drug Administration has approved a fusion protein made by Merck & Co. for a rare, life-threatening lung disorder. read more

FDA Approves Sotatercept, First-in-Class Treatment for Adults With PAH

1 The secondary end points, tested hierarchically, were multicomponent improvement, change in pulmonary vascular resistance, change in N-terminal pro-B-type natriuretic peptide level, improvement in ... read more

FDA Approves Macitentan, Tadalafil Combination Tablet for Pulmonary Arterial Hypertension

The approval, which marks the first for a once-daily, single-tablet combination therapy for pulmonary arterial hypertension, is based on findings from the phase 3 A DUE study. read more

FDA Approves Winrevair, Merck’s Novel Treatment for Pulmonary Arterial Hypertension

Winrevair is the first FDA-approved activin signaling inhibitor therapy for pulmonary arterial hypertension. read more

Johnson & Johnson Gets FDA Approval for Pulmonary Arterial Hypertension Pill

By Ben Glickman Johnson & Johnson's Opsynvi, a single-tablet combination of two existing compounds, has received approval from U.S. regulators to ... read more

Aerovate Therapeutics: A Strong Buy Ahead of Key Clinical Data Release

TD Cowen analyst Joseph Thome has maintained their bullish stance on AVTE stock, giving a Buy rating today. Joseph Thome has given his Buy ... read more

Johnson & Johnson announces approval of OPSYNVI for pulmonary arterial hypertension patients

In a significant milestone for pulmonary arterial hypertension (PAH) patients, Johnson & Johnson has announced the approval of OPSYNVI. read more

J&J Wins FDA Nod for Pulmonary Arterial Hypertension Combo Pill

Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, ... read more

Merck gets USFDA nod for WINREVAIR (sotatercept-csrk) for adults with pulmonary arterial hypertension

Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR, ... read more

FDA Approves Single-Tablet Combination of Macitentan and Tadalafil for Pulmonary Arterial Hypertension

In clinical trials, the newly approved Opsynvi led to a greater drop in pulmonary vascular resistance after 16 weeks compared with both tadalafil and macitentan monotherapy. read more
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