Pfizer and BioNTech SE announced positive preliminary results from the phase 1/2 study evaluating the safety, tolerability, and immunogenicity of escalating doses of the vaccine candidate BNT162b1 against COVID-19.
A NDA has been submitted to the FDA for udenafil to improve the physiology of patients aged ≥12 years with single ventricle heart disease (SVHD) who have undergone the Fontan operation.
The FDA has approved Dojolvi™ (triheptanoin; Ultragenyx) as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders.
Kiniksa Pharmaceuticals announced positive data from the phase 3 RHAPSODY trial evaluating rilonacept for the treatment of recurrent pericarditis.
The FDA has accepted for review the supplemental New Drug Application (sNDA) for sacubitril/valsartan (Entresto; Novartis) in the treatment of heart failure with preserved ejection fraction.
The Food and Drug Administration has approved Brilinta (ticagrelor; AstraZeneca) to reduce the risk of a first myocardial infarction (MI) or stroke in high-risk patients with coronary artery disease (CAD).
Researchers found that the drug regimens were associated with an increased risk of death even after accounting for factors such as age, race, BMI, and comorbidities.
Following clearance of an Investigational New Drug Application by the Food and Drug Administration, ViralClear announced that a phase 2 study evaluating merimepodib oral solution for the treatment of coronavirus disease 2019 (COVID-19) will be initiated.
Amarin Corporation announced results from the phase 3 REDUCE-IT study of icosapent ethyl (Vascepa) demonstrating a significant reduction in coronary revascularization procedures in high risk patients with mixed dyslipidemia.
Mavacamten is a novel, oral, selective allosteric inhibitor of cardiac myosin. It works by inhibiting excessive myosin-actin cross-bridge formation, thereby reducing excessive cardiac muscle contractility and increasing diastolic compliance.
