Bellerophon Therapeutics announced positive topline data from the phase 2b study of INOpulse® (pulsed, inhaled nitric oxide) delivery system for the treatment of pulmonary hypertension associated with pulmonary fibrosis (PH-PF).
The FDA has authorized marketing of Caption Guidance software (Caption Health) to assist medical professionals in the acquisition of cardiac ultrasound images.
The FDAhas granted Fast Track designation to APD418 (Arena Pharmaceuticals) for the treatment of decompensated heart failure.
The FDA has approved a new indication for Ozempic injection to reduce the risk of MACE with type 2 diabetes and established CVD.
The FDA has accepted the sNDA and granted Priority Review for Farxiga for CV death and worsening of heart failure.
The Food and Drug Administration (FDA) has approved the use of Vascepa (icosapent ethyl; Amarin Pharma) as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150mg/dL) and established CV disease or diabetes mellitus…
Bellerophon Therapeutics announced positive topline results from cohort 2 of an ongoing phase 2/3 iNO-PF study of INOpulse delivery system for the treatment of PH-ILD.
The FDA has approved Lumason, an ultrasound enhancing agent, for use in echocardiography to opacify the left ventricular chamber.
Fresenius Kabi has announced the availability of Heparin Sodium Injection 5000 USP units per 0.5mL for anticoagulation.
The FDA has approved the Prior Approval Supplement for Bretylium Tosylate Injection, allowing ANI Pharmaceuticals to market the once discontinued antiarrhythmic agent.
