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Results For "Food-and-Drug-Administration"

1069 News Found

Roche launches cobas 5800, a new molecular diagnostics system
Digitisation | November 18, 2021

Roche launches cobas 5800, a new molecular diagnostics system

The system is a compact new addition to the Roche Molecular portfolio, providing efficiency, simplicity and timely results to laboratories of all sizes.


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


Sluggish exports to cap pharma revenue growth at 9% this fiscal
News | November 17, 2021

Sluggish exports to cap pharma revenue growth at 9% this fiscal

A CRISIL study of 207 pharmaceutical companies that account for 55% of the Rs 3.2 lakh crore-a-year sector revenue indicates as much.


Pfizer seeks EUA from U.S. FDA for Covid-19 drug
Biotech | November 17, 2021

Pfizer seeks EUA from U.S. FDA for Covid-19 drug

If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2


U.S FDA authorises EaseVRx, immersive virtual reality for pain relief
Drug Approval | November 17, 2021

U.S FDA authorises EaseVRx, immersive virtual reality for pain relief

EaseVRx employs the principles of cognitive behavioural therapy and other behavioural therapy techniques for the reduction of pain and pain interference


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


IVD system to assist assay developers and clinical labs for molecular diagnostics
Medical Device | November 10, 2021

IVD system to assist assay developers and clinical labs for molecular diagnostics

Thermo Fisher Scientific expands diagnostics portfolio to support full qPCR assay development and testing workflow


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