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373 News Found

Evusheld significantly protected against symptomatic Covid-19 for at least six months
Biotech | April 21, 2022

Evusheld significantly protected against symptomatic Covid-19 for at least six months

Pre-exposure prevention trial reduced risk of symptomatic Covid-19, with no severe disease or Covid-19-related deaths in the Evusheld group


USFDA grants direct RMAT designation for the use of ExoFlo in Covid-19 related ARDS
Biotech | April 13, 2022

USFDA grants direct RMAT designation for the use of ExoFlo in Covid-19 related ARDS

An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)


Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer
Biotech | April 08, 2022

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer

The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC


CDSCO approves Phase II/III trial of Akston Bio’s Covid vaccine candidate in India
Biotech | April 08, 2022

CDSCO approves Phase II/III trial of Akston Bio’s Covid vaccine candidate in India

Veeda Clinical Research will submit data in an application for Emergency Use Authorisation


New data indicate molnupiravir eliminates Covid-19 rapidly
Biotech | April 03, 2022

New data indicate molnupiravir eliminates Covid-19 rapidly

Among patients with infectious virus at baseline, no patients who received Lagevrio had infectious virus at days 3, 5 or 10


EU approves Evusheld to prevent Covid-19
Drug Approval | March 28, 2022

EU approves Evusheld to prevent Covid-19

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months


New spesolimab data show promising results in patients with generalised pustular psoriasis flares
Biotech | March 28, 2022

New spesolimab data show promising results in patients with generalised pustular psoriasis flares

Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status


Phase 3 data show Dupixent improves signs and symptoms of prurigo nodularis
Biotech | March 27, 2022

Phase 3 data show Dupixent improves signs and symptoms of prurigo nodularis

There are currently no approved systemic treatments for prurigo nodularis; regulatory filings for prurigo nodularis planned in the first half of 2022


Evusheld recommended for market authorisation in EU
Biotech | March 25, 2022

Evusheld recommended for market authorisation in EU

Recommendation based on Phase III PROVENT trial showing a significant reduction in the risk of developing symptomatic COVID-19, with protection lasting at least six months


Roche to present data across neuroscience portfolio at 2022 AAN Annual Meeting
News | March 25, 2022

Roche to present data across neuroscience portfolio at 2022 AAN Annual Meeting

Additional data across neurological disorders, including Alzheimer’s disease, help advance the scientific understanding of these conditions and the potential impact of early treatment