EMA Regulatory News
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Biotechnology
The European Medicines Agency has granted marketing authorization to Jazz Pharmaceuticals for Enrylaze (JZP458). 22 September 2023
Biosimilars
Following a favorable recommendation form the European Medicines Agency’s advisory committee on July, the European Commission (EC) has now granted marketing authorization in the European Union (EU) for Indian drugmaker Biocon’s Yesafili, a biosimilar of Eylea (aflibercept). 21 September 2023
Pharmaceutical
Italian drugmaker Menarini has secured European approval for Orserdu (elacestrant) as a monotherapy for the treatment of certain people with advanced or metastatic breast cancer. 21 September 2023
Biosimilars
The European Commission (EC) has granted marketing authorization for Fresenius Kabi’s biosimilar of Actemra/RoActemra (tocilizumab). 20 September 2023
Pharmaceutical
The European Commission has authorized Apretude (cabotegravir long-acting [LA] injectable and tablets) for HIV prevention, from ViiV Healthcare, the specialist HIV company majority-owned by UK Pharma major GSK. 19 September 2023
Biotechnology
Sino-American biotech BeiGene today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize Tevimbra (tislelizumab). 19 September 2023
Biotechnology
The European Commission (EC) has become the third medicines regulator to grant marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. 19 September 2023
Pharmaceutical
The European Commission (EC) has approved Otsuka Pharmaceutical and its subsidiary Astex Pharmaceuticals’ Inaqovi (oral decitabine and cedazuridine) as monotherapy for the treatment of adults with newly-diagnosed acute myeloid leukemia (AML) who are ineligible for standard induction chemotherapy. 19 September 2023
Pharmaceutical
A cancer drug under development by Cellectar Biosciences, a company based in New Jersey, USA, has been awarded an expedited review framework from the European Medicines Agency. 19 September 2023
Biotechnology
The European Medicines Agency (EMA) has recommended not renewing the marketing authorization for Translarna (ataluren). 18 September 2023
Pharmaceutical
Significant changes to the way European health technology assessments (HTA) take place is underway, with a transitional period set to be in force for several years. 18 September 2023
Pharmaceutical
Following its September 2023 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval of six novel medicines. 15 September 2023
Pharmaceutical
The European Medicines Agency (EMA) has validated Japanese pharma major Astellas Pharma’s Type II variation for Xtandi (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC). 13 September 2023
Pharmaceutical
Italy’s privately-held drug developer Italfarmaco Group today revealed that its Marketing Authorization Application (MAA) for Givinostat as a potential treatment for Duchenne muscular dystrophy (DMD) has been submitted to the European Medicine Agency. 5 September 2023
Pharmaceutical
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy. 4 September 2023
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended authorizing a version of BioNTech and Pfizer’s Comirnaty COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant. 30 August 2023
Pharmaceutical
The European Commission (EC) has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorization to include infants with a clinical diagnosis of spinal muscular atrophy (SMA) type one, type two or type three or with one to four SMN2 copies from birth to below two months. 29 August 2023
Biotechnology
New York-based pharma giant Pfizer has secured a European approval for Abrysvo, an innovative vaccine to prevent infection with respiratory syncytial virus (RSV). 25 August 2023
Biotechnology
Bristol Myers Squibb has been granted a new European approval for Opdivo (nivolumab) as a monotherapy in skin cancer. 23 August 2023
Biotechnology
The European Commission (EC) has granted conditional marketing authorization (CMA) of Talvey (talquetamab), developed by Janssen Pharmaceuticals. 22 August 2023
Pharmaceutical
AstraZeneca has received European approval for a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, for adults newly diagnosed with chronic lymphocytic leukemia (CLL). 6 June 2025
Pharmaceutical
The European Commission has granted market authorization for Japanese ophthalmic drugmaker Santen Pharmaceutical’s Ryjunea, a low-dose atropine eye drop (0.1mg/ml), that slows the progression of pediatric myopia, marking a significant advance in pediatric eye care. 5 June 2025
Pharmaceutical
The European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to include a new, room-temperature stable tablet for people living with spinal muscular atrophy (SMA), Swiss pharma giant Roche revealed today 4 June 2025
Biotechnology
The European Commission (EC) has approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. 4 June 2025
Pharmaceutical
Shares in MaaT Pharma, a French microbiome company in oncology, closed 25% higher Tuesday. 3 June 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 2 June 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its May 2025 meeting. Final approvals from the European Commission are now expected in the third quarter of this year. 23 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) Emergency Task Force (EFT) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign. 19 May 2025
Pharmaceutical
Vaccines Europe’s response to the Call for Evidence on the European Centre for Disease Prevention and Control evaluation Vaccines Europe (VE) welcomes the evaluation of the European Centre for Disease Prevention and Control (ECDC). 19 May 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
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