European Medicines Agency
European Medicines Agency recommended 104 medicines for approval in 2025
January 20, 2026Research and Development European Medicines Agency, Rare Diseases
The European Medicines Agency (EMA) has announced data from 2025 showing that over the course of the year it recommended …
Sanofi’s treatment granted orphan designation for rare chronic inflammatory condition
August 14, 2025Medical Communications, Research and Development European Alliance of Associations for Rheumatology, European Medicines Agency, IgG4-related disease, Rheumatology, Sanofi
The European Medicines Agency has granted orphan designation to Sanofi’s investigational Bruton’s tyrosine kinase (BTK) inhibitor, rilzabrutinib, for the treatment …
Johnson & Johnson seeks EMA approval to accelerate prostate cancer treatment
July 4, 2025Medical Communications, Research and Development European Medicines Agency, Genito-Urinary system, Johnson & Johnson, Oncology, clinical trial, prostate cancer
Johnson & Johnson has submitted an application to the European Medicines Agency for an indication extension of Akeega (niraparib and …
Sarclisa recommended for EU approval in newly diagnosed multiple myeloma
June 24, 2025Research and Development Committee for Medicinal Products for Human USE, EU, European Commission, European Medicines Agency, German-speaking Myeloma Multicenter Group, Oncology, Sanofi, blood cancer, monoclonal antibody
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s Sarclisa (isatuximab) for approval in …
CHMP issues positive opinion for Blenrep combinations in relapsed/refractory multiple myeloma
May 23, 2025Market & Product Development, Medical Communications, Research and Development Blenrep, Committee for Medicinal Products for Human USE, European Medicines Agency, Oncology, multiple myeloma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion …
Novartis’ Mayzent granted license by the European Medicines Agency
January 21, 2020Manufacturing and Production CNS, European Medicines Agency, NHS, NICE, Novartis
The European Medicines Agency (EMA) has granted a licence for the use of Mayzent (siponimod) in the treatment of certain …
CHMP rejects AB Science’s ALS therapy in Europe
April 23, 2018Sales and Marketing AB Sciences, EMA, European Medicines Agency, ab science, als, masitinib, pharma
AB Science has revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a …
European Medicines Agency: Staying consistent in a turbulent time
June 12, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, European Medicines Agency, brexit
With Brexit looming, the future of the EMA headquarters in London has been cast in doubt. Pharmafocus spoke to Marie-Agnes …
GSK’s gene therapy for rare condition in children gets EMA backing
April 4, 2016Research and Development, Sales and Marketing ADA-SCID, European Medicines Agency, GlaxoSmithKline, Orphan Therapy, Rare Treatment, drug trial, gene therapy
UK drug major GlaxoSmithKline (LSE: GSK) has won marketing recommendation from European regulators for its first gene therapy to treat …
European Medicines Agency elects Christa Wirthumer-Hoche as new chair of management board
March 21, 2016Medical Communications, Research and Development Christa Wirthumer-Hoche, EMA, European Medicines Agency, chair, chairperson, wirthumer-hoche
Christa Wirthumer-Hoche has been elected chair of the management board of the European Medicine’s Agency. She has served as vice …
EMA adds warning label to Novartis’ MS treatment Gilenya
December 22, 2015Manufacturing and Production EMA, European Medicines Agency, FDA, Novartis, PML, basal cell carcinoma, fingolimod, gilenya
Drug safety regulators in Europe have said they will add warnings to the label and prescribing information of Gilenya (fingolimod), …
EMA management board chair stands down
December 21, 2015Manufacturing and Production, Sales and Marketing EMA, European Medicines Agency, Sir Kent Woods
Sir Kent Woods will step down as chair of the board at the EMA from the end of December 2015. …
Janssen submits Stelara for EU approval for Crohn’s
December 9, 2015Sales and Marketing Crohn’s disease, EMA, European Medicines Agency, Janssen, Stelara, crohn's disease, ustekinumab
Janssen today announced that it has submitted an application to the European Medicines Agency, seeking approval of Stelara in Crohn’s …
EMA launches scheme to prioritise medicines access for patients
October 27, 2015Manufacturing and Production EMA, European Medicines Agency, medicines access
The EMA has launched a public consultation on a scheme which aims to enable access to more medicines.The PRIME scheme …
Novartis’ Cosentyx gets European approval for two conditions
October 23, 2015Medical Communications, Sales and Marketing Cosentyx, European Medicines Agency, Novartis, psoriatic arthritis
The scientific committee of the European Medicines Agency (EMA) has recommended the approval of Novartis’ Cosentyx (secukinumab) for treatment of ankylosing …
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