Abbott’s 15-Minute COVID-19 Antigen Test Gets Emergency Use Authorization
The FDA issued an Emergency Use Authorization for BinaxNOW™ COVID-19 Ag Card a rapid antigen test for the detection of COVID-19.
The FDA issued an Emergency Use Authorization for BinaxNOW™ COVID-19 Ag Card a rapid antigen test for the detection of COVID-19.
The application is supported by data from the multicenter, double-blind, placebo-controlled phase 2/3 SELECT-AXIS 1 study.
A phase 1 study of AstraZeneca’s investigational monoclonal antibody AZD7442 for COVID-19 has been initiated.
Orphengesic Forte for the symptomatic relief of mild to moderate pain of acute musculoskeletal disorders is now available.
HHS issued the amendment in order to increase access to childhood vaccines and decrease the risk of vaccine-preventable disease outbreaks as children return to daycare and school.
Novavax announced positive phase 1 data of its COVID-19 vaccine candidate, NVX-CoV2373.
A phase 3 study of tocilizumab for the treatment of hospitalized patients with severe COVID-19 pneumonia did not meet its primary and key secondary end points.
The FDA will give Priority Review to the New Drug Application (NDA) of voclosporin for the treatment of lupus nephritis.
Interim results from the phase 1/2 COV001 trial evaluating the vaccine candidate ChAdOx1 nCoV-19 (AZD1222) showed that vaccination led to strong immune responses.
The FDA has approved the supplemental Abbreviated New Drug Application (sANDA) for Orphengesic Forte.