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Results For "phase-3"

732 News Found

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


Merck showcases potential for several cancers, MS and lupus
News | November 22, 2021

Merck showcases potential for several cancers, MS and lupus

Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline


U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism
Drug Approval | November 20, 2021

U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism

Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth


Daiichi Sankyo initiates Phase 2 trial of mRNA Covid-19 vaccine in Japan
Biotech | November 18, 2021

Daiichi Sankyo initiates Phase 2 trial of mRNA Covid-19 vaccine in Japan

It is anticipated to be safe and efficacious by targeting the receptor-binding domain (RBD) of the new coronavirus


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


Covaxin well tolerated with no safety concerns: Lancet
News | November 12, 2021

Covaxin well tolerated with no safety concerns: Lancet

Covaxin is the only Covid-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the Delta variant at 65.2%


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


Bristol Myers neoadjuvant Opdivo (nivolumab) plus chemotherapy assists cancer patients effectively
Biotech | November 09, 2021

Bristol Myers neoadjuvant Opdivo (nivolumab) plus chemotherapy assists cancer patients effectively

Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma


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


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