Author Archives: Marisa Wexler MS

FDA Approves Clinical Trial of TIVUS System in PAH

The U.S. Food and Drug Administration (FDA) has granted SoniVie permission to begin a pivotal clinical trial of its Therapeutic Intra-Vascular Ultrasound (TIVUS) System in people with pulmonary arterial hypertension (PAH). This “study will provide important information on the safety and efficacy of the TIVUS System in…

FDA Reviewing Application for Tyvaso as Treatment for PH-ILD

The U.S. Food and Drug Administration (FDA) has accepted for review the  application for Tyvaso (inhaled treprostinil) as a potential treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The supplemental new drug application (sNDA) was submitted by United Therapeutics,…

Reata Stops Bardoxolone PAH Trials Amid COVID-19 Concerns

Reata Pharmaceuticals is stopping clinical trials evaluating bardoxolone methyl in people with pulmonary arterial hypertension (PAH), including a Phase 3 study, to ensure the safety of participants during the COVID-19 pandemic, the company announced. Trials in other disorders are set to continue, although some will stop…