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Results For "regulatory"

1216 News Found

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


Hester Biosciences to acquire 50 % stake in Thrishool Exim, Tanzania
News | November 11, 2021

Hester Biosciences to acquire 50 % stake in Thrishool Exim, Tanzania

The consideration for the acquisition is US $ 2.25 million


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


Moderna seeks approval from EMA for its Covid-19 vaccine for children between 6-11 years
News | November 10, 2021

Moderna seeks approval from EMA for its Covid-19 vaccine for children between 6-11 years

The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11


EVA Pharma to open vaccine manufacturing facility in Cairo
Supply Chain | November 09, 2021

EVA Pharma to open vaccine manufacturing facility in Cairo

The new facility will provide an important boost to vaccine capacity in Africa


Pfizer’s Covid-19 drug a potential game changer
Biotech | November 08, 2021

Pfizer’s Covid-19 drug a potential game changer

In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo


Novavax files emergency use listing with WHO for Covid-19 vaccine
Biotech | November 05, 2021

Novavax files emergency use listing with WHO for Covid-19 vaccine

All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO


UK authorises first Covid-19 pill
News | November 05, 2021

UK authorises first Covid-19 pill

Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency


Moderna and Metagenomi partner to develop next-gen in vivo gene editing therapeutics
Biotech | November 03, 2021

Moderna and Metagenomi partner to develop next-gen in vivo gene editing therapeutics

The collaboration will combine Metagenomi’s next-generation CRISPR-based and other novel gene editing systems with Moderna’s mRNA and LNP technologies


WHO issues emergency use listing for Covaxin
News | November 03, 2021

WHO issues emergency use listing for Covaxin

This is the eighth Covid-19 vaccine to receive Emergency Use Listing