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.
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Lenzilumab is an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
The EUA was issued based on 4 randomized controlled clinical trials that evaluated the efficacy and safety of Actemra in more than 5500 hospitalized patients with COVID-19.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
Kineret is an interleukin-1 receptor antagonist.
InflaRx is working to increase supply of the product in the US as quickly as possible.
The FDA has approved Octapharma’s Investigational New Drug Application allowing the Company to initiate a phase 3 trial of Octagam® (immune globulin intravenous [human]) in patients with COVID-19 with severe disease progression.
The Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection; Astellas Pharma) for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients aged <4 months.
The Simplist ready-to-administer prefilled syringes require no assembly or point-of-care preparation.