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Results For "submission"

300 News Found

Pfizer’s Covid-19 drug 90 % effective
News | December 15, 2021

Pfizer’s Covid-19 drug 90 % effective

The data has been shared with the U.S.FDA as part of an ongoing rolling submission for Emergency Use Authorisation


Aragen Life Sciences acquires Intox
Biotech | December 15, 2021

Aragen Life Sciences acquires Intox

Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune


Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan
Biotech | December 14, 2021

Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan

In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020


Medicago and GSK’s plant based Covid-19 vaccine candidate show promise in Phase 3 trials
Biotech | December 10, 2021

Medicago and GSK’s plant based Covid-19 vaccine candidate show promise in Phase 3 trials

Primary endpoints and secondary endpoints for which data are available were met in trial dominated by Covid-19 variants


Cytel and Pulse Infoframe to transform rare disease research landscape
Biotech | December 10, 2021

Cytel and Pulse Infoframe to transform rare disease research landscape

Both companies will combine their expertise to channel real-world evidence toward ground-breaking new treatments in rare diseases


Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


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


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


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