EMA Archives

News and Trends 27 Jan 2023

EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease

BioArctic AB's partner Eisai says the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab. Lecanemab,…

January 27, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

Dupixent gets EU nod for children with severe atopic dermatitis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab), recommending…

January 27, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 26 Jan 2023

Milestone for gene-edited therapy for sickle cell disease

Vertex Pharmaceuticals (Europe) and CRISPR Therapeutics have announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application…

January 26, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 3 Jan 2023

Janssen looks for talquetamab marketing approval

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a marketing authorisation application (MAA) to the European Medicines Agency…

January 3, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 16 Dec 2022

CSL closer to gene therapy treatments for hemophilia B patients in Europe

CSL says the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion…

December 16, 2022 - 2 minutesmins - By Jim Cornall

In Depth 15 Dec 2022

To avoid stagnation, the EU must refine its ATMP regulation

Over the decades, the EU has spearheaded the adoption of advanced therapy medicinal products (ATMPs) such as cell and gene…

December 15, 2022 - 8 minutesmins - By Jonathan Smith

News and Trends 15 Dec 2022

EMA gives Myrtelle’s Canavan disease gene therapy candidate OD designation

Myrtelle Inc., a clinical stage gene therapy company, has announced that the European Medicines Agency (EMA) has granted orphan drug…

December 15, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 5 Dec 2022

Positive antibody persistence for vaccine treating mosquito disease

A single shot vaccine for mosquito-borne disease chikungunya has had positive antibody persistence data 12 months after vaccination. The primary…

December 5, 2022 - 3 minutesmins - By Liza Laws

More News! 30 Nov 2022

FDA grants Sensorion Orphan Drug Designation for hearing loss drug

Sensorion a clinical-stage biotechnology company has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation…

November 30, 2022 - 3 minutesmins - By Liza Laws

News and Trends 18 Nov 2022

AstraZeneca and Daiichi Sankyo’s Enhertu recommended for approval

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) for patients previously treated HER-2 positive advanced…

November 18, 2022 - 3 minutesmins - By Liza Laws

More News! 14 Nov 2022

Minoryx and Neuraxpharm form alliance to get rights to new therapy for rare CNS disease

Minoryx Therapeutics and Neuraxpharm Group have announced a strategic alliance for the European rights to a new therapy for rare…

November 14, 2022 - 3 minutesmins - By Liza Laws

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…

November 14, 2022 - 4 minutesmins - By Liza Laws