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News and Trends

Prurigo nodularis treatment recommended for EU approval  

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a…

By Jim Cornall
November 11, 2022 - 3 minutes
News and Trends

Sanofi and GSK Covid-19 booster vaccine approved by European Commission

Sanofi and GSK’s Covid booster vaccine has been approved in Europe. After the European Medicines…

By Jim Cornall
November 10, 2022 - 2 minutes
More News!

Sensorion granted rare pediatric disease designation by FDA for lead therapy gene

Sensorion has announced that the US Food and Drug Administration (FDA) has granted rare pediatric…

By Liza Laws
November 7, 2022 - 2 minutes
News and Trends

Accelerated application for drug to help immunodeficiency submitted by Pharming

A marketing authorization application (MAA) has been submitted by Dutch company Pharming Group, to the…

By Liza Laws
October 11, 2022 - 4 minutes
News and Trends

Treatment for hot flushes and night sweats accepted for regulatory review by EMA

A treatment for moderate to severe vasomotor symptoms (VMS) has been accepted by the European…

By Liza Laws
September 30, 2022 - 2 minutes
News and Trends

CHMP recommends approval of Beyfortus for prevention of RSV disease in infants

Beyfortus, which is being developed jointly by Sanofi and AstraZeneca, is a step closer to…

By Jim Cornall
September 16, 2022 - 4 minutes
News and Trends

Sensorion receives positive opinion from EMA for treatment of hearing loss

The European Medicines Agency (EMA) through its Committee for Orphan Medicinal Products (COMP) has adopted…

By Liza Laws
September 12, 2022 - 3 minutes
News and Trends

Emactuzumab designated as an orphan medicinal product for TGCT in Europe

SynOx Therapeutics Limited says its novel monoclonal antibody, emactuzumab, in development for the treatment of…

By Jim Cornall
August 31, 2022 - 4 minutes
News and Trends

Marketing authorization granted for treatment of serious retinal diseases

The European Commission has granted marketing authorization to Ranivisio, a treatment for several serious retinal…

By Liza Laws
August 29, 2022 - 3 minutes
News and Trends

First gene therapy for adults with severe hemophilia approved by EC

The European Commission (EC) has granted conditional marketing authorization for a gene therapy to treat…

By Liza Laws
August 26, 2022 - 3 minutes
News and Trends

Drug to treat rare kidney disease to be reviewed by EMA

The European Medicines Agency (EMA) has agreed to review a conditional marketing authorization (CMA) application…

By Liza Laws
August 22, 2022 - 3 minutes
News and Trends

Treatment for patients with fragile skin disease accepted by FDA

The U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license…

By Liza Laws
August 19, 2022 - 3 minutes
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