EMA Regulatory News
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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
Biotechnology
Johnson & Johnson (NYSE: JNJ) has received a new European approval for a combination of Rybrevant (amivantamab) plus chemotherapy in lung cancer. 28 June 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines and one biosimilar for approval at its June 2024 meeting. 28 June 2024
Biotechnology
Swiss pharma giant Roche has announced that the European Commission has granted marketing authorization for Ocrevus (ocrelizumab) subcutaneous (SC) to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 25 June 2024
Pharmaceutical
As anticipated following a positive scientific opinion, British pharma major AstraZeneca's Truqap (capivasertib) has been approved by the European Union. 20 June 2024
Biotechnology
The European Commission has granted marketing authorization for Altuvoct (efanesoctocog alfa), for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A. 19 June 2024
Pharmaceutical
In Europe, revised rules for the Clinical Trials Information System (CTIS) are now applicable, offering faster access to clinical trial information. 18 June 2024
Biotechnology
At its June meeting, the European Medicines Agency’s (EMA) pharmacovigilance committee, PRAC, came to the conclusion that patients treated with CAR T-cell medicines should be monitored life-long for secondary malignancies. 14 June 2024
Pharmaceutical
In a blog post, the general counsel of European trade group EFPIA - the European Federation of Pharmaceutical Industries and Associations - has argued for effective incentives to be included in the EU general pharmaceutical legislation. 10 June 2024
Biotechnology
A report from industry analyst GlobalData finds that reforms to the European Union's general pharmaceutical legislation have become a pivotal policy development for the pharma industry. 6 June 2024
Pharmaceutical
Italy’s Philogen and Indian drugmaker Sun Pharmaceutical Industries have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy (daromun). 5 June 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended eight novel drugs for approval at its May 2024 meeting. 31 May 2024
Pharmaceutical
Danish allergy immunotherapy specialist ALK Abell today revealed that its European regulatory filing for Itulazax (tree sublingual allergy immunotherapy [SLIT] tablet) in young children has been accepted for review by the relevant health authorities. 30 May 2024
Biosimilars
The European Commission (EC) has approved Omlyclo (CT-P39), an omalizumab biosimilar referencing Xolair. 24 May 2024
Pharmaceutical
The European Commission (EC) has approved the label update of both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolaemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. 24 May 2024
Biosimilars
The European Commission has presented European Union (EU) guidance on public procurement of medicines which is critical to improve the security of supply for patients and health systems. 24 May 2024
Biosimilars
Swiss generic and biosimilar medicines company Sandoz today announced that the European Commission (EC) has granted marketing authorization for Wyost (denosumab) and Jubbonti (denosumab), the first and only biosimilar versions of reference medicines Xgeva and Prolia in Europe. 22 May 2024
Biotechnology
The European Commission (EC) has decided not to adopt the European Medicines Agency’ human medicines committee CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna (ataluren) and has returned the opinion to the CHMP for re-evaluation. 21 May 2024
Pharmaceutical
At its meeting this week the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) reviewed medicines regarding their safety. 17 May 2024
Biotechnology
Swedish Orphan Biovitrum has announced that the European Commission (EC) has approved an indication extension for Aspaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who have hemolytic anemia. 8 May 2024
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