Drugs in the Pipeline, News
The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
News
The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
Drugs in the Pipeline
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients.
Drugs in the Pipeline
Findings showed that the trial did not meet statistical significance on the primary endpoint.
News
The FDA approved Veklury (remdesivir; Gilead Sciences) for the treatment of COVID-19 in patients aged ≥12 years (weighing ≥40kg) requiring hospitalization.
Drugs in the Pipeline
The ACTT-2 study began on May 8 and included more than 1000 patients.
Drugs in the Pipeline
The sBLA is supported by data from 4 randomized, controlled studies that evaluated tocilizumab for the treatment of COVID-19 in more than 5500 hospitalized patients.
Drugs in the Pipeline
Lenzilumab is an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
Drugs in the Pipeline
The update was based on data from the COV-BARRIER study.
News
The study, which was fully remote and contactless, aimed to evaluate whether early treatment with fluvoxamine reduced the likelihood of clinical deterioration and disease severity in patients with mild COVID-19 illness.