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Biosimilars
Access to therapies used to treat major chronic diseases remains particularly limited in Central and Eastern Europe (CEE). Off patent medicines are often the first opportunity for patients to access the essential medicines they need, says Medicines for Europe, the trade body representing bakers of biosimilar and generic drugs. 16 November 2022
Pharmaceutical
The European Commission (EC) has granted approval for the marketing authorization application for Livtencity (maribavir) that was submitted by Japan’s largest drugmaker Takeda. 14 November 2022
Biosimilars
Following its November 2022 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four medicines for approval, one a biosimilar, two generics and the other a coronavirus vaccine. 11 November 2022
Biotechnology
There is a new COVID-19 booster vaccine in town, just in time for Europe’s fall and winter season. 11 November 2022
Biosimilars
The European Commission has granted a marketing authorization for Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis, developed by Germany’s STADA Arzneimittel and Sweden’s Xbrane Biopharma. 11 November 2022
Biotechnology
The European Commission (EC) has approved Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. 4 November 2022
Biotechnology
Long available in Europe under an emergency nod, AstraZeneca's COVID-19 vaccine, Vaxzevria, has finally been granted full approval in the region. 1 November 2022
Biotechnology
In a move that may have a significant impact on some big selling drugs, the European Medicines Agency’s safety committee (PRAC) today recommended measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. 28 October 2022
Biotechnology
The European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for lebrikizumab for the treatment of moderate to severe atopic dermatitis submitted by Almirall. 28 October 2022
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. 20 October 2022
Biotechnology
Gilead Sciences has won European approval for Yescarta (axicabtagene ciloleucel) for the treatment of certain adults with different kinds of large B-cell lymphoma (LBCL). 18 October 2022
Biotechnology
The European Medicines Agency (EMA) today announced recommendations made by its human medicines committee (CHMP) following its October 2022 meeting. 14 October 2022
Biotechnology
Dutch rare disease specialist Pharming has moved a step closer to marketing authorization for leniolisib in Europe. 11 October 2022
Biotechnology
The UK’s BioIndustry Association (BIA), the trade body for innovative life sciences, has welcomed a one-year extension to the European Commission Decision Reliance Procedure (ECDRP). 11 October 2022
Pharmaceutical
Market authorization was granted to 92 new medicines in the European Union (EU) last year.Market authorization was granted to 92 new medicines in the European Union (EU) last year. 5 October 2022
Pharmaceutical
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for Japanese drugmaker Astellas Pharma’s fezolinetant. 30 September 2022
Pharmaceutical
Drugmakers in Europe are arguing for a new economic model for reimbursement of antibiotics, paving the way for a breakthrough in the fight against antimicrobial resistance. 28 September 2022
Biotechnology
Developed by UK pharma major AstraZeneca, Ultomiris (ravulizumab) has been approved in Europe for a new indication. 23 September 2022
Biotechnology
Nine months after gaining its first approval in the USA, AstraZeneca’s Tezspire (tezepelumab) has now been approved in the European Union (EU). 21 September 2022
Pharmaceutical
The European Commission (EC) has granted marketing authorization for Nulibry (fosdenopterin) for Injection as the first therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. 20 September 2022
Pharmaceutical
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins. 4 July 2025
Biosimilars
Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for Vevzuo and Evfraxy biosimilars of denosumab, originated by Amgen. 4 July 2025
Pharmaceutical
Alnylam Pharmaceuticals has won European Commission approval for Amvuttra (vutrisiran) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM), positioning the drug as a likely challenger to entrenched therapies in a market expected to see rapid evolution. 2 July 2025
Biotechnology
US biotech Jazz Pharmaceuticals yesterday announced that the European Commission (EC) has granted conditional marketing authorization for Ziihera (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, with the news edging its shares up 3.1% to $109.44. 2 July 2025
Pharmaceutical
Vertex Pharmaceuticals today announced that the European Commission has granted approval for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) for the treatment of people with cystic fibrosis (CF) ages six years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 1 July 2025
Biotechnology
Italian drugmaker Philogen has announced its decision to voluntarily withdraw the application for marketing authorization to the European Medicines Agency (EMA) for Nidlegy(daromun), a biological investigational medicinal product which is intended to be used for the neoadjuvant treatment of adult patients with locally advanced fully resectable melanoma. 27 June 2025
Biotechnology
US biotech PTC Therapeutics’ (Nasdaq: PTCT) Sephience (sepiapterin) has been granted marketing authorization by the European Commission for the treatment of children and adults living with phenylketonuria (PKU). The authorization includes a broad label inclusive of all ages and disease severities. 25 June 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its June 2025 meeting. 20 June 2025
Pharmaceutical
French drug developer Averoa today announced that the European Commission (EC) has granted marketing authorization for Xoanacyl (ferric citrate coordination complex). 16 June 2025
Pharmaceutical
Privately-held Italian pharma company Italfarmaco today revealed that the European Commission (EC) has granted conditional marketing authorization for Duvyzat (givinostat), a novel histone deacetylase (HDAC) inhibitor. 9 June 2025
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
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