EMA Archives

More News! 14 Nov 2022

BioSenic’s autoimmune disease platform adapting to meet unmet medical needs

BioSenic’s systemic autoimmune disease platform, originally designed by Medsenic, is now developing controlled dosages and new formulations adapted to a significant number of important indications with unmet medical needs. BioSenic specializes in serious autoimmune and inflammatory diseases as well as cell repair. The update follows the announcement of the merger between Bone Therapeutics and Medsenic […]

November 14, 2022 - 4 minutesmins - By Liza Laws

News and Trends 11 Nov 2022

Prurigo nodularis treatment recommended for EU approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent (dupilumab) in the European Union (EU) to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Dupilumab is being jointly developed by Sanofi and Regeneron. The European Commission is expected […]

November 11, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 10 Nov 2022

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 Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn Beta, the vaccine was approved by the European Commission, as a booster for the prevention of Covid-19 in adults 18 years of age and older. […]

November 10, 2022 - 2 minutesmins - By Jim Cornall

More News! 7 Nov 2022

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 disease designation to its lead therapy gene candidate, OTOF-GT. The gene therapy is intended for the treatment of otoferlin gene mediated hearing loss. Sensorion’s OTOF-GT gene therapy development program aims to restore hearing in people living with otoferlin deficiency, one […]

November 7, 2022 - 2 minutesmins - By Liza Laws

News and Trends 11 Oct 2022

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 European Medicines Agency (EMA) for a rare, primary immunodeficiency in adults and adolescents 12 years and older. Activated phosphonide 3-kinase delta syndrome (APDS), first discovered in 2013, is caused by genetic variants in either one of two identified genes known […]

October 11, 2022 - 4 minutesmins - By Liza Laws

News and Trends 30 Sep 2022

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 Medicines Agency (EMA) for regulatory review. Astellas Pharma Inc., submitted a marketing authorization application (MAA) for fezolinetant, an investigational oral, nonhormonal compound. VMS is characterized by hot flushes and/or night sweats which are common menopausal symptoms. Hot flushes The news […]

September 30, 2022 - 2 minutesmins - By Liza Laws

News and Trends 16 Sep 2022

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 preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Beyfortus (nirsevimab) for the prevention of RSV lower respiratory […]

September 16, 2022 - 4 minutesmins - By Jim Cornall

News and Trends 12 Sep 2022

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 a positive opinion for a treatment for otoferlin gene mediated hearing loss. Clinical-stage biotech, Sensorion, announced the news today (September 12) that its application for an Orphan Drug Designation (ODD) for its lead therapy gene candidate, OTOF-GT will now be […]

September 12, 2022 - 3 minutesmins - By Liza Laws

News and Trends 31 Aug 2022

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 tenosynovial giant cell tumor (TGCT) and other diseases, has been designated as an orphan medicinal product for both localized and diffuse types of the disease by the European Medicines Agency (EMA). No systemic treatments have been approved for TGCT in […]

August 31, 2022 - 4 minutesmins - By Jim Cornall

News and Trends 29 Aug 2022

Marketing authorization granted for treatment of serious retinal diseases

The European Commission has granted marketing authorization to Ranivisio, a treatment for several serious retinal diseases. Polpharma Biologics Group BV, Formycon AG and their Swiss joint venture, Bioeq AG, announced the news today (August 29) that the authorization was granted to Ranivisio, which is a biosimilar to Lucentis, a ranibizumab injection. Positive opinion: CHMP The […]

August 29, 2022 - 3 minutesmins - By Liza Laws

News and Trends 26 Aug 2022

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 severe hemophilia A in adults it was announced yesterday (August 25). BioMarin Pharmaceutical Inc.’s Roctavian (valoctocogene roxaparvovec) treats the congenital factor 8 deficiency in adults patients without a history of factor VIII inhibitors without detectable antibodies to adeno-associated virus serotype […]

August 26, 2022 - 3 minutesmins - By Liza Laws

News and Trends 22 Aug 2022

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 for a drug to treat a rare kidney disorder. The news was announced today (August 21) by CSL Vifor and Travere Therapeutics Inc, and, if approved, the companies say sparsentan will address a significant unmet need in treating IgA nephropathy […]

August 22, 2022 - 3 minutesmins - By Liza Laws

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EMA

BioSenic’s autoimmune disease platform adapting to meet unmet medical needs

Prurigo nodularis treatment recommended for EU approval

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

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

Accelerated application for drug to help immunodeficiency submitted by Pharming

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

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

Sensorion receives positive opinion from EMA for treatment of hearing loss

Emactuzumab designated as an orphan medicinal product for TGCT in Europe

Marketing authorization granted for treatment of serious retinal diseases

First gene therapy for adults with severe hemophilia approved by EC

Drug to treat rare kidney disease to be reviewed by EMA

Subscribe to our newsletter to get the latest biotech news!

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

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Advertise with us

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