Prurigo nodularis treatment recommended for EU approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a…
November 11, 2022 - 3 minutes
EMA
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…
November 10, 2022 - 2 minutes
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…
November 7, 2022 - 2 minutes
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…
October 11, 2022 - 4 minutes
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…
September 30, 2022 - 2 minutes
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…
September 16, 2022 - 4 minutes
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…
September 12, 2022 - 3 minutes
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…
August 31, 2022 - 4 minutes
Marketing authorization granted for treatment of serious retinal diseases
The European Commission has granted marketing authorization to Ranivisio, a treatment for several serious retinal…
August 29, 2022 - 3 minutes
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…
August 26, 2022 - 3 minutes
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…
August 22, 2022 - 3 minutes
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…
August 19, 2022 - 3 minutes
