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Biotechnology
The European Commission has granted marketing authorization for Kostaive (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older, from Australia’s CSL Limited and US sa-mRNA pioneer Arcturus Therapeutics, whose shares rose 10% to $18.05 on the news. 15 February 2025
Biotechnology
Switzerland’s Galderma today announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). 14 February 2025
Biotechnology
The European Commission (EC) has approved Andembry (garadacimab), the first and only once-monthly treatment targeting factor XIIa to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. 13 February 2025
Biotechnology
The European Commission (EC) has approved catumaxomab, making it the only approved drug therapy for malignant ascites (MA) for patients living with this debilitating condition across Europe. 13 February 2025
Biotechnology
The European Commission has granted marketing authorization in the European Union (EU) for acoramidis, under the brand name Beyonttra, for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). 11 February 2025
Biotechnology
Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, has submitted a Marketing Authorization Application (MAA) for the gene therapy etuvetidigene autotemcel to the European Medicines Agency (EMA). 3 February 2025
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the publication of the Competitiveness Compass by the European Commission (EC) and the recognition of the role that innovation in life sciences can play in reigniting competitiveness in the European Union (EU). 3 February 2025
Pharmaceutical
As of today, all clinical trials in the European Union (EU), including those that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical Trials Regulation (CTR). 31 January 2025
Pharmaceutical
The European Commission (EC) has authorized the combination of ViiV Healthcare’s Vocabria (cabotegravir long-acting injections) and Johnson & Johnson’s Rekambys (rilpivirine long-acting injections) to treat HIV-1 infection in adolescents of 12 years of age and older and weighing at least 35 kg who are virologically suppressed. 31 January 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines for approval at its January 2025 meeting, as well as some biosimilars. 31 January 2025
Biotechnology
The European Commission (EC) has approved Blincyto (blinatumomab) monotherapy as part of consolidation therapy for the treatment of adults with newly-diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). 30 January 2025
Pharmaceutical
The European Shortages Monitoring Platform (ESMP) is now live, with the full scope of functionalities. 29 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen, marketed as Spinraza, for spinal muscular atrophy (SMA). 23 January 2025
Biotechnology
French pharma giant Sanofi has secured European Union approval for Sarclisa (isatuximab) for certain people with newly diagnosed multiple myeloma. 22 January 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Lazcluze (lazertinib), in combination with Rybrevant amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations. 21 January 2025
Biotechnology
The European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, UK pharma major GSK announced today. 20 January 2025
Biotechnology
Germany’s Formycon and its licensing partner Klinge Biopharma have announced that the European Commission (EC) has granted central marketing authorization for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama. 20 January 2025
Pharmaceutical
The European Medicines Agency (EMA) today revealed that, in 2024, it recommended 114 medicines for marketing authorization. Of these, 46 had a new active substance which had never been authorized in the European Union (EU) before. 16 January 2025
Biosimilars
Teva Pharmaceuticals has partnered with Klinge Biopharma and Formycon to commercialize FYB203, a biosimilar to Eylea (aflibercept), in Europe and Israel. 13 January 2025
Biosimilars
The US Food and Drug Administration approved 50 novel drugs in 2024, continuing to outpace its global regulatory peers. 10 January 2025
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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