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366 News Found

Lilly's tirzepatide delivered up to 22.5% weight loss in adults with obesity
Biotech | April 29, 2022

Lilly's tirzepatide delivered up to 22.5% weight loss in adults with obesity

Participants taking tirzepatide lost up to 52 lb. (24 kg) in this 72-week phase 3 study


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


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


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