Tag: PAH

Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept, an Activin Signaling Inhibitor to Treat Adults with Pulmonary Arterial Hypertension (PAH)

RAHWAY, N.J.–(BUSINESS WIRE)–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 accepted for priority review a new Biologics License Application (BLA) for sotatercept, Merck’s novel […]

Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH)

Exploratory post-hoc analysis of STELLAR shows potential of sotatercept to improve cardiovascular function Interim results from SOTERIA open-label extension study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy […]

Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking Approval of Single Tablet Combination Therapy (STCT) of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)

This is the first and only single tablet combination therapy to be submitted for review in Europe for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guideline-recommended treatment pathways BEERSE, Belgium, June […]

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)

This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease   If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guidelines-recommended treatment pathways […]

Pulnovo Medical Reports Positive One-year Results for PADN-CFDA Trial in Pulmonary Arterial Hypertension (PAH) Treatment

SHANGHAI, Feb. 27, 2023 /PRNewswire/ — Pulnovo Medical Limited, a globally recognized OTM platform, announced positive one-year results from the Pulmonary Artery Denervation (PADN)-CFDA pivotal study at the industry’s most leading American Cardiovascular Research Technologies conference (CRT 2023). PADN is an innovative radiofrequency […]

Aerami Therapeutics Announces Expansion of the AER-901 (inhaled imatinib) Development Program in Pulmonary Hypertension Supported by Phase 1 Clinical Trial Data and Continued Progress

Expansion of the AER-901 development program to include pulmonary hypertension associated with interstitial lung disease (PH-ILD) builds on the company’s existing program in pulmonary arterial hypertension (PAH) PH-ILD shares clinical and pathophysiological features with PAH, however, there is only one […]

Aerami Therapeutics Announces Completion of Dosing in Phase 1 Trial of AER-901 (inhaled imatinib), a Critical Milestone Toward the Planned Initiation of a Phase 2 Trial in Pulmonary Arterial Hypertension (PAH) During the First Half of 2023

AER-901 (inhaled imatinib), a potential reverse-remodeling therapy, is being developed to address unmet need for PAH treatments that target pulmonary vascular remodeling while supporting ease-of-use for patients. PAH is a rare and progressive disease with no cure; pulmonary vascular remodeling […]

Liquidia Announces Collaboration to Develop a New Infusion Pump for Subcutaneous Delivery of Treprostinil Injection to Treat Pulmonary Arterial Hypertension (PAH)

Liquidia and Sandoz will collaborate with Mainbridge Health Partners to develop a new infusion pump Liquidia and Sandoz have also extended the term of their promotion agreement for Treprostinil Injection until 2032 MORRISVILLE, N.C., Dec. 05, 2022 (GLOBE NEWSWIRE) — […]