You are here: Industry Insights > EUA

News List

Precision Genetics Advances COVID-19 Testing by Adding Saliva Collection Under Existing EUA prnewswire
October 22, 2020
Precision Genetics, a leading healthcare technology company and high capacity molecular testing lab, has added saliva collection to their existing portfolio of validated Covid-19 testing options submitted under Emergency Use Authorization (EUA) by the ...
Genalyte Obtains EUA for Rapid COVID-19 Antibody Test americanpharmaceuticalreview
October 22, 2020
Genalyte announced its SARS-CoV-2 Multi-Antigen Serology Panel has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
FDA issues guidance on emergency use authorisation for COVID-19 vaccines expresspharma
October 10, 2020
In the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine's safety and effectiveness.
Eli Lilly seeks EUA for monotherapy against Covid-19 pharmaceutical-technology
October 10, 2020
Eli Lilly has submitted an application to the US Food and Drug Administration (FDA) seeking emergency use authorisation (EUA) for LY-CoV555 monotherapy for treating higher-risk patients with mild-to-moderate Covid-19.
EUA requested for potential COVID-19 respiratory failure treatment europeanpharmaceuticalreview
September 27, 2020
An Emergency Use Authorization (EUA) request for the use of RLF-100™ (aviptadil) in critical COVID-19 patients was submitted to the US FDA.
Moderna would seek EUA in US for COVID-19 vaccine based on early data expresspharma
September 18, 2020
If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90 per cent efficacy, we will indeed consider approval, said company CEO.
Improving FDA's COVID-19 vaccine authorization and approval process worldpharmanews
September 02, 2020
On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of COVID-19.
FDA Broadens EUA for Remdesivir for COVID-19 americanpharmaceuticalreview
September 01, 2020
The U.S. Food and Drug Administration (FDA) has broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or ...
US FDA willing to give EUA for COVID-19 vaccines before Phase III trials expresspharma
September 01, 2020
FDA Commissioner also said that it is not a blanket approval and will be subject to benefits outweighing the risks.
US FDA broadens EUA for Veklury (remdesivir) to treat all hospitalised COVID-19 patients expresspharma
August 31, 2020
The expansion is supported by the FDA’s analysis of additional data from two randomised, controlled clinical trials that included patients with mild or moderate disease.

Previous page 1 2 3 4 5 6 7 8 Next page