The FDA has granted Priority Review of the supplemental New Drug Application for Brilinta (ticagrelor; AstraZeneca), for use in combination with aspirin, to reduce the rate of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack.
Nexlizet (bempedoic acid and ezetimibe; Esperion) is now available for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
The phase 2b trial is expected to include roughly 2000 participants with confirmed SARS-CoV-2 who are experiencing fever, cough, and/or shortness of breath.
An AP-rated and therapeutically equivalent generic of Cardene IV (Chiesi) has been made available by American Regent.
The FDA has granted Fast Track designation to omecamtiv mecarbil (Amgen) for the potential treatment of chronic heart failure with reduced ejection fraction (HFrEF).
A phase 2 study of Moderna’s vaccine candidate for COVID-19, mRNA-1273, is expected to start shortly following the Food and Drug Administration’s review of the Company’s Investigational New Drug (IND) application.
In a press briefing, NIAID Director and White House health advisor Dr Anthony Fauci compared the positive results of this highly powered, placebo-controlled trial to the discovery of the first HIV drug over 30 years ago. “This will be the standard of care,” said Fauci.
The Agency is warning the public that the use of these agents should be limited to clinical trial settings or for treating certain hospitalized patients under the Emergency Use Authorization.
A phase 3 trial evaluating ruxolitinib (Jakafi; Incyte) for the treatment of coronavirus disease 2019 (COVID-19)-associated cytokine storm is being initiated in patients 12 years of age and older.
The FDA has launched a new webpage with information for recovered individuals who were infected with coronavirus disease 2019 (COVID-19) on where they can go to donate plasma to aid in the treatment of severely ill patients.
