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Results For "regulatory"

1625 News Found

Sanofi and IGM Biosciences team up to commercialise IgM antibody agonists
Biotech | March 30, 2022

Sanofi and IGM Biosciences team up to commercialise IgM antibody agonists

Companies to leverage proprietary IgM antibody technology platform to discover agonists against three oncology targets and three immunology/inflammation targets


OPPI summit calls for collaboration across stakeholders
News | March 30, 2022

OPPI summit calls for collaboration across stakeholders

The summit also saw the launch of two important reports- Multi-Regional Clinical Trials (MRCT) and Value of OTC in India


USFDA approves CartiHeal's implant for the treatment of cartilage and osteochondral defects
Drug Approval | March 30, 2022

USFDA approves CartiHeal's implant for the treatment of cartilage and osteochondral defects

Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of Agili-C™ implant to the current surgical standard of care, debridement and microfracture in the knee joint


NAMSA to acquire European-based Medanex clinic
Biotech | March 30, 2022

NAMSA to acquire European-based Medanex clinic

World-leading companies, as well as small innovative research groups, regularly partner with Medanex for their outstanding cardiovascular services and timely, efficacious study outcomes.


ASC Therapeutics gets green light to advance gene therapy for Hemophilia A
Biotech | March 30, 2022

ASC Therapeutics gets green light to advance gene therapy for Hemophilia A

A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies


Dupixent is a star in Sanofi’s immunology strategy
Biotech | March 29, 2022

Dupixent is a star in Sanofi’s immunology strategy

Dupixent peak sales ambition raised to more than €13 billion


Alembic Pharma acquires 100% stake in Aleor Dermaceuticals
News | March 29, 2022

Alembic Pharma acquires 100% stake in Aleor Dermaceuticals

The amalgamation will integrate business operations and provide impetus to the existing portfolio of Alembic


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