EMA Regulatory News
Refine Search
Biotechnology
Brussels-based UCB (OTCMKTS: UCBJF) has announced that it has received marketing authorization from the European Commission for two new 320 mg device presentations of Bimzelx (bimekizumab). 5 August 2024
Biotechnology
WuXi Biologics (2269.HK), a major Chinese contract research, development, and manufacturing organization (CDMO), has had four facilities certified by the European Medicines Agency. 1 August 2024
Biosimilars
Chinese biotech Bio-Thera Solutions (SHSE: 688177) has picked up European Medicines Agency approval for BAT1706, a biosimilar referencing Avastin (bevacizumab). 1 August 2024
Biotechnology
The European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion. 30 July 2024
Biosimilars
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has adopted positive opinions for six biosimilar medicines. 27 July 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines for approval at its July 2024 meeting. 26 July 2024
Biotechnology
EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing authorization approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab). 26 July 2024
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for Durveqtix (fidanacogene elaparvovec), from US pharma giant Pfizer 25 July 2024
Biosimilars
Gedeon Richter today announced that the European Medicines Agency (EMA) has accepted the company’s two marketing authorization applications (MAAs) for its proposed biosimilar to denosumab. 19 July 2024
Pharmaceutical
Ono Pharmaceuticalannounced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib. 19 July 2024
Pharmaceutical
Spanish drugmaker PharmaMar has received a notification from the European Commission (EC) advising that it is revoking the refusal to grant a Marketing Authorization (MA) for Aplidin (plitidepsin) in multiple myeloma. 15 July 2024
Biotechnology
AbbVie on Friday revealed it has submitted applications for a new indication to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Rinvoq (upadacitinib) 15mg, once daily for the treatment of adult patients with giant cell arteritis (GCA). 15 July 2024
Pharmaceutical
Following its July 2024 meeting, the European Medicines Agency’s (EMA) safety committee (PRAC) has recommended new measures on the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs). 13 July 2024
Pharmaceutical
The European authorities have granted marketing authorization for Livmarli (maralixibat), for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients from the age of three months. 10 July 2024
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) noted in a posting on its website that European Union legislation will shape the future pf research, development and manufacturing in Europe for decades to come. 8 July 2024
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca’s Tagrisso (osimertinib) has won a new approval in the European Union (EU). 5 July 2024
Biotechnology
The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD). 3 July 2024
Pharmaceutical
Pierre Fabre revealed that the European Commission (EC) has authorized the marketing of its Obgemsa (vibegron) for the symptomatic treatment of overactive bladder syndrome in adults. 2 July 2024
Biotechnology
Specialty vaccine company Valneva has announced that the European Commission (EC) has granted marketing authorization for its single-dose vaccine, Ixchig, for the prevention of disease caused by the chikungunya virus in people aged 18 years of and older. 1 July 2024
Biotechnology
AstraZeneca’s Marketing Authorization Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. 1 July 2024
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 8 May 2025
Pharmaceutical
Following a European Union-wide review of available data on finasteride and dutasteride medicines, the European Medicines Agency’s (EMA) safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1mg and 5mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. 8 May 2025
Biotechnology
Sino-American biotech BeiGene today announced that the European Commission has approved Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). 8 May 2025
Pharmaceutical
UK pharma major AstraZeneca today revealed that its Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. 6 May 2025
Pharmaceutical
The European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for Filspari (sparsentan). 29 April 2025
Biotechnology
Regeneron Pharmaceuticals today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma. 28 April 2025
Pharmaceutical
The European Medicines Agency’s (EMA)) human medicines committee (CHMP) has recommended seven novel medicines for approval at its April 2025 meeting. A final decision from the European Commission is usually issued in about two months. 26 April 2025
Biotechnology
The European Commission (EC) has approved a marketing authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 25 April 2025
Pharmaceutical
Denmark-based allergy immunotherapy specialist ALK Abello today announced that its Itulazax (tree pollen sublingual allergy immunotherapy tablet) has been approved by the European regulator for treatment of young children and adolescents aged five to 17. 23 April 2025
Biotechnology
The European Commission (EC) has at last granted the amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) Marketing Authorization (MA) in the European Union (EU). 16 April 2025
Biotechnology
The European Commission has approved Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT), Swiss pharma giant Roche announced this morning. 14 April 2025
Pharmaceutical
The European Commission (EC) has granted marketing authorization to Rinvoq (upadacitinib; 15mg, once daily), from US pharma major AbbVie , for the treatment of giant cell arteritis (GCA) in adult patients. 9 April 2025
Biotechnology
Datroway (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. 8 April 2025
Biotechnology
Following hot on the heels of Monday’s European Commission EC approval of an indication extension for Johnson & Johnson’s Darzalex (daratumumab) for the treatment of adult patients with newly diagnosed multiple myeloma, comes a second EC approval today – this time in lung cancer. 8 April 2025
Pharmaceutical
US biotech company Vertex Pharmaceuticals has received European Commission approval to extend the use of its cystic fibrosis therapy, Kaftrio (ivacaftor/tezacaftor/elexacaftor), in combination with ivacaftor. 8 April 2025
Biotechnology
The European Commission (EC) has approved an indication extension of Darzalex (daratumumab) subcutaneous (SC) formulation in the frontline setting. 7 April 2025
Pharmaceutical
A key result of recent European workshops is that drug studies should be designed in such a way that they address both regulatory questions and the essential research questions of benefit assessments. 7 April 2025
Biotechnology
UK pharma major AstraZeneca today reported extended approvals in Europe for two of its cancer drugs: Imfinzi (durvalumab) and Enhertu (trastuzumab deruxtecan). 4 April 2025
Biotechnology
The European Medicines Agency has temporarily suspended enrollment and dosing in a Phase II trial of Sarepta Therapeutics' gene therapy, Elevidys (delandistrogene moxeparvovec-rokl), for Duchenne muscular dystrophy (DMD). 3 April 2025
Biosimilars
The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. 2 April 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze