FDA authorizes emergency use of remdesivir
The Food and Drug Administration Friday issued Gilead Sciences an emergency use authorization for the investigational antiviral drug remdesivir to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
FDA previously allowed for study of the drug under clinical trials, as well as expanded access use for individual patients and through a multi-patient expanded access program coordinated by Gilead.
The National Institutes of Health this week reported that a clinical trial provided preliminary indications that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received a placebo.
Related News Articles
Headline
Flu cases are growing or likely growing in 39 states, according to the latest Centers for Disease Control and Prevention data from Nov. 11. COVID-19…
Headline
The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled…
Headline
A study published Oct. 30 by the American Heart Association found that people have an elevated risk of heart attack and stroke following flu and COVID-19…
Headline
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations…
Headline
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial…
Headline
The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following…