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Results For "EUA"

106 News Found

Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark
Medical Device | December 06, 2021

Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark

The combination rapid antigen test quickly differentiates between SARS-CoV-2 and influenza viruses A and B infections, with results ready in less than 30 minutes, allowing informed decisions on patient and pandemic management decisions


ZyCoV-D to be initially administered in seven states
News | December 02, 2021

ZyCoV-D to be initially administered in seven states

The three doses of ZyCoV-D are to be administered 28 days apart. The vaccine was given emergency use authorisation (EUA) by the Indian drug regulator on August 20


Molnupiravir, a step closer to approval in the fight against Covid-19
News | December 02, 2021

Molnupiravir, a step closer to approval in the fight against Covid-19

The U.S. FDA advisory committee voted 13-10 in favour of the oral antiviral medicine


Vivera announces launch of new testing software, LabPort
Digitisation | November 24, 2021

Vivera announces launch of new testing software, LabPort

Featuring identity verification using artificial intelligence (AI), LabPort was designed to facilitate immediate results reporting for diagnostic testing even in high-volume, field-based testing environments


U.S. FDA allows Pfizer and Moderna booster doses for all
News | November 20, 2021

U.S. FDA allows Pfizer and Moderna booster doses for all

This is a shot in the arm for the vaccine manufacturers


US govt signs deal with GSK and Vir Biotechnology to buy sotrovimab, a Covid-19 treatment
Biotech | November 18, 2021

US govt signs deal with GSK and Vir Biotechnology to buy sotrovimab, a Covid-19 treatment

The final data from the trial showed sotrovimab reduces hospitalisation and risk of death by 79% in adults with mild-to-moderate Covid-19 who are at high risk of progression to severe disease


European Commission approves Celltrion’s Covid-19 medicine
Drug Approval | November 15, 2021

European Commission approves Celltrion’s Covid-19 medicine

The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week


Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay
Biotech | November 12, 2021

Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay

The company expects to begin shipping this product before the end of its fiscal first quarter, ending December 31, 2021


Sun Pharma to introduce molnupiravir in India
Drug Approval | November 12, 2021

Sun Pharma to introduce molnupiravir in India

The Drug Controller General of India (DCGI), is reviewing clinical data of molnupiravir for the treatment of Covid-19 in adults in India


US govt places additional order of 1.4 million courses of molnupiravir
News | November 10, 2021

US govt places additional order of 1.4 million courses of molnupiravir

Molnupiravir is an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in at risk adults