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Pharmaceutical
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralized clinical trials (DCTs). 20 December 2022
Biotechnology
The European Commission (EC) has granted marketing authorization for Ebvallo (tabelecleucel)vas a monotherapy for treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein Barr virus positive post transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. 19 December 2022
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) recommended four novel medicines for approval at its December 2022 meeting. A final approval decision from the European Commission can be expected within the next two or three months. 16 December 2022
Biotechnology
The European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged two months and older. 15 December 2022
Biotechnology
Adding to a string of approved indications for the interleukin (IL) and IL-4 blocking antibody, the European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. 15 December 2022
Biotechnology
As anticipated, following a positive decision from its scientific committee, the European Medicines Agency has granted marketing authorization for Pluvicto (vipivotide tetraxetan). 14 December 2022
Biotechnology
The marketing authorization application (MAA) for momelotinib, an investigational oral treatment for myelofibrosis, submitted by UK pharma major GSK, has been accepted by the European Medicines Agency (EMA). 7 December 2022
Pharmaceutical
Following a review, the European Medicines Agency’s (EMA) Emergency Task Force (ETF) has concluded that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 may be used for initial vaccination. 7 December 2022
Biotechnology
The European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for aumolertinib, a third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI). 2 December 2022
Pharmaceutical
Today, the Pediatric Praziquantel Consortium announced that the European Medicines Agency (EMA) has validated for review the application for arpraziquantel for the treatment of schistosomiasis in preschool-aged children (three months to six years of age), submitted by its partner, German pharma and life sciences firm Merck KGaA. 2 December 2022
Biotechnology
In another boost for AbbVie (NYSE: ABBV), the European Commission (EC) has granted a third approval of Skyrizi (risankizumab, 600mg intravenous [IV] induction and 360mg subcutaneous [SC] for maintenance therapy). 24 November 2022
Pharmaceutical
Needing to keep pace with the pace of innovation set by drugmakers, the European Medicines Agency (EMA) has responded by setting up a new group. 22 November 2022
Biotechnology
French drugmaker Sanofi has added a European approval to those in the USA and Japan for Enjaymo (sutimlimab) to treat hemolytic anemia in adults with cold agglutinin disease (CAD). 18 November 2022
Biotechnology
The European Commission today granted marketing authorization for Sino-American biotech BeiGene’s Brukinsa (zanubrutinib) for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. 17 November 2022
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
Last week, a US Food and Drug Administration (FDA) advisory committee (AdCom) voted against approval of Danish drugmaker Lundbeck and Japan-based Otsuka’s Rexulti for post-traumatic stress disorder. France’s Sanofi announced it is expanding its respiratory vaccines pipeline with an up to $1.6 billion acquisition of UK biotech Vicebio. French biotech Abivax released new Phase III data on its investigational ulcerative colitis candidate obefazimod that saw its shares nearly quadruple. Also of note was the latest setback for Sarepta’s Duchenne muscular dystrophy drug Elevidys, when the European Medicines human health committee, the CHMP, declined partner Roche’s accelerated approval of the drug. 27 July 2025
Biotechnology
As if there had not been enough negative news regarding Elevidys (delandistrogene moxeparvovec) this month, there was more today from the European regulator. 25 July 2025
Pharmaceutical
The European Medicines’ (EMA) human medicines committee (CHMP) has recommended seven novel medicines for approval at its July 2025 meeting. 25 July 2025
Biotechnology
French drugmaker Ipsen announced that the European Commission (EC) has approved Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. 25 July 2025
Biotechnology
In an import contrast to events in the USA, UK pharma major GSK late Thursday announced the approval of Blenrep (belantamab mafodotin) by the European Commission. 25 July 2025
Biotechnology
Following the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on June 19, 2025, the European Commission has approved French pharma major Sanofi's (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. 25 July 2025
Biotechnology
US healthcare giant Johnson & Johnson (NYSE: JNJ) has announced that the European Commission (EC) has approved a new indication and an indication extension for Darzalex (daratumumab) and Imbruvica (ibrutinib), respectively. 23 July 2025
Pharmaceutical
Privately-held Spanish CNS specialist Minoryx Therapeutics and Germany’s Neuraxpharm Group today announced that the marketing authorization application (MAA) for Minoryx’ lead candidate Nezglyal (leriglitazone) has been submitted to the European Medicines Agency (EMA) for the treatment of pediatric and adult male patients with cerebral adrenoleukodystrophy (cALD). 23 July 2025
Biotechnology
The European Commission has approved Swiss pharma giant Roche’s Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. 23 July 2025
Biotechnology
French biotech ImCheck Therapeutics has announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, in acute myeloid leukemia (AML). 22 July 2025
Pharmaceutical
The European Commission has granted marketing authorization in the European Union (EU) for German pharma major Bayer’s Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT), for a third therapeutic indication. 21 July 2025
Biotechnology
The European Commission granted conditional marketing authorization for Ezmekly (mirdametinib) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged two years and above. 19 July 2025
Pharmaceutical
At its July meeting, the European Medicines Agency’s pharmacovigilance committee (PRAC) completed its review of French specialty vaccine maker Valneva Ixchiq (chikungunya virus vaccine, a live attenuated chikungunya vaccine, following reports of serious side effects. 11 July 2025
Biotechnology
The European Commission has approved Tevimbra (tislelizumab), alongside gemcitabine and cisplatin, for the first-line treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. 10 July 2025
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
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