EMA Regulatory News
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Biotechnology
Almirall has won European Commission (EC) approval for Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. 17 November 2023
Biotechnology
The European Commission (EC) has granted marketing authorization for China-headquartered biotech BeiGene’s Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma. 17 November 2023
Biotechnology
Following US approval in the same indication earlier this year, Japanese drugmaker Daiichi Sankyo’s Vanflyta (quizartinib) has now also been approved in the European Union (EU). 13 November 2023
Biosimilars
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines and two biosimilars for approval at its November 2023 meeting. 11 November 2023
Biotechnology
The European Medicines Agency (EMA) has validated the submission for Braftovi (encorafenib) with Mektovi (binimetinib), submitted by privately-held French drugmaker Pierre Fabre, for the treatment of adult patients with BRAFV600-mutant advanced non-small cell lung cancer (NSCLC). 2 November 2023
Biotechnology
On Tuesday, US biotech company Novavax, which is advancing protein-based vaccines with its Matrix-M adjuvant, announced a timely update with its Nuvaxovid XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted). 1 November 2023
Biotechnology
An updated version of the coronavirus vaccine developed by Novavax has been approved in Europe, after a positive scientific opinion. 1 November 2023
Pharmaceutical
There was good news for the makers of some diabetes and obesity drugs today, when the European regulator found no link to thyroid cancer scares. 27 October 2023
Biosimilars
The European Union is currently reviewing its pharmaceutical legislation, and the latest IQVIA white paper “Assessing the biosimilar void” sheds light on the growing biological medicines market and the opportunity to improve equitable access with biosimilar medicines competition. 26 October 2023
Pharmaceutical
Privately-held French company Orphelia Pharma, which is focused on pediatric and orphan medicines, has filed a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kizfizo, the first oral liquid formulation of temozolomide. 24 October 2023
Biotechnology
Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). 23 October 2023
Biotechnology
The European Commission (EC) has now approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma. 19 October 2023
Pharmaceutical
At its October monthly meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval. 14 October 2023
Biotechnology
Johnson & Johnson’s Janssen subsidiary has submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for Rybrevant (amivantamab). 10 October 2023
Pharmaceutical
Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) has responded critically to a reflection paper by the European Medicines Agency (EMA) on the approval of new drugs based on single-arm studies. 9 October 2023
Pharmaceutical
Leading regulatory bodies around the world have various pathways in place to speed up the approval process for promising medicines that offer a solution to unmet medical needs. 6 October 2023
Pharmaceutical
The European Medicines Agency (EMA) today revealed it has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). 6 October 2023
Pharmaceutical
Addressing what has been dubbed the ‘triple A’ challenge of access, affordability and availability has been an objective of the European Medicines Agency (EMA) for nearly 30 years, going back to the launch of the centralized procedure in 1995. 29 September 2023
Biosimilars
The European Commission (EC) granted marketing authorization for Tyruko (natalizumab), the first and only biosimilar multiple sclerosis drug, developed by Dutch company Polpharma Biologics. 26 September 2023
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. 25 September 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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