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Results For "clinical-trial"

768 News Found

Pharming gets positive review from UK MHRA for leniolisib
Biotech | April 26, 2022

Pharming gets positive review from UK MHRA for leniolisib

A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA's Early Access to Medicines Scheme


DCGI grants Covaxin Emergency Use Approval for children 6-12 years
Drug Approval | April 26, 2022

DCGI grants Covaxin Emergency Use Approval for children 6-12 years

Covaxin was earlier approved for children 12-18 years of age


ZyCoV-D two-dose vaccine receives Emergency Use Approval from DCGI
Drug Approval | April 26, 2022

ZyCoV-D two-dose vaccine receives Emergency Use Approval from DCGI

The two-dose regimen for ZyCoV-D was tested in 3100 healthy volunteers more than 12 years of age


Shilpa Medicare receives NoC for biosimilar Aflibercept
Biotech | April 25, 2022

Shilpa Medicare receives NoC for biosimilar Aflibercept

Aflibercept is the second biosimilar product that has entered the clinical trial phase after biosimilar Adalimumab


Shionogi’s once-a-day Covid-19 anti-viral shows rapid virus clearance
Biotech | April 25, 2022

Shionogi’s once-a-day Covid-19 anti-viral shows rapid virus clearance

A separate global Phase 3 study of S-217622 is underway aiming to recruit participants globally to support regulatory filings this year


Porton Advanced and Sinorda Biomedicine collaborate for cell therapy development for solid tumours
Biotech | April 25, 2022

Porton Advanced and Sinorda Biomedicine collaborate for cell therapy development for solid tumours

Under the agreement, Porton Advanced will provide services to accelerate the development, production and registration of breakthrough cell therapies currently being developed by Sinorda Biomedicine


NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency
Biotech | April 23, 2022

NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency

Heavy bleeding after giving birth is globally a leading cause of death in new mothers


Novavax initiates Covid-19 booster study in adolescents in Phase 3 trial
Biotech | April 23, 2022

Novavax initiates Covid-19 booster study in adolescents in Phase 3 trial

Continuation of pediatric expansion in adolescents of PREVENT-19 Phase 3 trial will evaluate safety and immunogenicity of a booster dose


USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial
Biotech | April 22, 2022

USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial

The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic


Veeva Vault CTMS launched at Bristol Myers Squibb
Medical Device | April 21, 2022

Veeva Vault CTMS launched at Bristol Myers Squibb

Bringing together Bristol Myers Squibb and Celgene on one clinical trial management system, company goes live with Vault CTMS in record speed