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FDA grants EUA for Lilly and Incyte’s baricitinib for Covid-19 treatment
pharmaceutical-technology
November 23, 2020
The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for Eli Lilly and Company and Incyte’s baricitinib in combination with remdesivir in hospitalised patients with Covid-19.
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US FDA grants EUA to monoclonal antibodies from Regeneron for COVID-19 treatment
expresspharma
November 23, 2020
In a clinical trial, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalisation or emergency room visits in patients at high risk for disease progression within 28 days after treatment.
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FDA Approves Liquid Biopsy NGS Companion Diagnostic Test
americanpharmaceuticalreview
November 20, 2020
The U.S. Food and Drug Administration (FDA) approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic device for multiple additional biomarkers detected in ...
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FDA to review Samsung Bioepis and Biogen’s biosimilar SB11
pharmaceutical-technology
November 20, 2020
The US Food and Drug Administration (FDA) has accepted Samsung Bioepis and Biogen’s biologics licence application to review the use of SB11 as a biosimilar referencing Lucentis (ranibizumab).
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Olumniant (barcitinab) from Eli Lilly gets EUA from US FDA for COVID-19 treatment
expresspharma
November 20, 2020
The US Food and Drug Administration (USFDA) issued an emergency use authorisation (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalised adults and pediatric ...
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Amylyx announces FDA granted orphan drug designation for AMX0035 to treat Wolfram syndrome
pharmaceutical-business-review
November 19, 2020
Amylyx Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035 for the treatment of Wolfram syndrome.
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Lupin announces FDA filing acceptance of sNDA for Solosec to treat trichomoniasis
pharmaceutical-business-review
November 18, 2020
Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for Solosec® (secnidazole) for the treatment of trichomoniasis in adults and adolescents.
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Inovio to start mid-stage trials of its COVID-19 vaccine
expresspharma
November 18, 2020
The US FDA had put Phase 3 of the mid-to-late stage trial on hold, and sought more information, including details on a delivery device used to inject genetic material into cells.
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CARE Receives May Proceed Letter from FDA for COVID-19 Trial
americanpharmaceuticalreview
November 17, 2020
Senhwa Biosciences announced its clinical partner, Center for Advanced Research and Education (CARE) in Gainesville, Georgia, has received a Study May Proceed letter from the US Food and Drug Administration (FDA) to begin a phase II ...
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FDA approves Merck’s Keytruda with chemotherapy to treat breast cancer
pharmaceutical-technology
November 17, 2020
Merck (MSD) has secured approval from the US Food and Drug Administration (FDA) for its Keytruda in combination with chemotherapy for treating patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumours ..