The EUA recommendation was based on data from the placebo-controlled COVE study that investigated the efficacy and safety of mRNA-1273 in more than 30,000 adults aged 18 years and older.
This is the first time the Agency has authorized a COVID-19 diagnostic test that provides rapid results at home.
The placebo-controlled COVE study is investigating the efficacy and safety of mRNA-1273 at the 100mcg dose (given intramuscularly in a 2-dose series, approximately 28 days apart) in more than 30,000 adults aged 18 years and older.
Available as a sulfate-based tablet, Sutab provides an alternative to liquid-based colonoscopy preparations.
The trial will continue as planned and final analysis is expected when the number of confirmed COVID-19 cases reaches 164.
The True North study included patients with moderate to severe ulcerative colitis who had an inadequate response to prior treatment.
The bile acid sequestrant was designed to be maintained in the stomach over an extended period of time where it was expected to intercept bile before it reached the esophagus.
The vaccine candidate is currently in preclinical development with clinical studies expected to begin later this year.
The FDA has approved a new ready-to-dilute liquid formulation of Akynzeo® injection (fosnetupitant/palonosetron; Helsinn) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, in combination with dexamethasone in adults.