EMA Regulatory News
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Pharmaceutical
At its March management board meeting, the European Medicines Agency adopted the EMA’s annual report for 2023, noting that, in 2023, Agency recommended 77 medicines for marketing authorization for human use, 39 of which had a new active substance, and adopted the EMA’s annual report for 2023. 23 March 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its March 2024 meeting. 22 March 2024
Biotechnology
The European Commission (EC) has granted expanded approval for the cell therapy Abecma (idecabtagene vicleucel; ide-cel). 21 March 2024
Biotechnology
Firms with an interest in artificial intelligence (AI), such as Microsoft and Nvidia, led US stock markets to new heights last year, as investors sought to price in imagined productivity gains from new AI technologies. 15 March 2024
Pharmaceutical
Pfizer has won European Commission (EC) approval for Prevenar 20 for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in children aged from six weeks to less than 18 years. 13 March 2024
Pharmaceutical
Data protection is in the spotlight in Europe, as lawmakers gather to decide on an important set of rules on intellectual property, the Regulatory Data Protection (RDP) law. 11 March 2024
Biotechnology
The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in two types of cancer. 4 March 2024
Pharmaceutical
Drugmakers, patient advocate groups, policymakers and others have come together for Rare Disease Day, which took place at the end of February, to both celebrate progress and call for more action in this therapy area. 4 March 2024
Pharmaceutical
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
Pharmaceutical
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorization for Nezglyal (leriglitazone) following a re-examination of the filing. 29 February 2024
Biosimilars
Medicines for Europe, a trade group for the European generics industry, has welcomed the position adopted today by the European Parliament regarding SPC regulation. 28 February 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines and one biosimilar for approval at its February 2024 meeting. 23 February 2024
Pharmaceutical
The European Commission (EC) has granted marketing authorization for Velsipity (etrasimod) to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC). 19 February 2024
Biotechnology
Genetic disease company Vertex Pharmaceuticals has secured conditional marketing authorization for Casgevy (exagamglogene autotemcel) in Europe. 13 February 2024
Pharmaceutical
The European Commission (EC) has authorized Biogen’s Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. 13 February 2024
Pharmaceutical
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with the COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir). 9 February 2024
Pharmaceutical
All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by January 31, 2025. 31 January 2024
Pharmaceutical
Indian drugmaker Orchid Pharma's antibiotic drug Exblifep (cefepime/enmetazobactam) has received approval from the European Medicines Agency (EMA), leading to a 20% surge in the company's stock. 30 January 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Omjjara (momelotinib), a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. 29 January 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its January 2024 meeting, but rejected two others. 26 January 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
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