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Results For "regulatory"

1529 News Found

Jubilant HollisterStier plans US $92 mn expansion
News | November 13, 2021

Jubilant HollisterStier plans US $92 mn expansion

The 50,000 square foot expansion will house a high-speed filling line and lyophilizers, which will increase the facility’s sterile injectable capacity by 50%


European Commission approves Ronapreve to treat Covid-19
Drug Approval | November 13, 2021

European Commission approves Ronapreve to treat Covid-19

Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus


Ronapreve gets the green light from CHMP to treat non-hospitalised Covid-19 patients
Biotech | November 12, 2021

Ronapreve gets the green light from CHMP to treat non-hospitalised Covid-19 patients

A final decision regarding the approval of Ronapreve is expected from the European Commission shortly


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