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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
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
Qulipta (atogepant) has taken another step on its way to becoming a significant force in the world of calcitonin gene-related peptide (CGRP) receptor blocking migraine drugs. 18 July 2022
Pharmaceutical
The European Commission (EC) has granted conditional marketing authorization for Kinpeygo (budesonide) for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. 16 July 2022
Biosimilars
Poland-based drugmaker Polpharma Biologics today announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to branded multiple sclerosis treatment Tysabri. 15 July 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Pfizer and BioNTech’s COVID-19 vaccine, known as Comirnaty (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. 9 July 2022
Pharmaceutical
The European Medicines Agency has identified measures to address medicine shortages during public health emergencies, following a meeting of a steering group devoted to this task. 8 July 2022
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures to minimize the risk of meningioma with medicines containing nomegestrol or chlormadinone, which are used for gynecological and menstrual disorders, hormone replacement therapy and, at lower doses, as hormonal contraceptives (birth control). 8 July 2022
Pharmaceutical
Regulators have discussed emerging evidence to support the adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve. 1 July 2022
Pharmaceutical
Bavarian Nordic has announced that its respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in older adults has been granted PRIME eligibility by the European Medicines Agency (EMA). 28 June 2022
Biotechnology
The European Commission (EC) has approved Sanofi’s Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy to treat non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. 28 June 2022
Biotechnology
The European Commission (EC) has approved its CAR-T cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. 28 June 2022
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from monkeypox disease. 28 June 2022
Biotechnology
The European Commission has granted marketing authorization for Nexviadyme (avalglucosidase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder, from French pharma major Sanofi. 28 June 2022
Biotechnology
Leading PARP blocker Lynparza (olaparib) looks set to secure a new marketing authorization in Europe, after a positive scientific opinion. 27 June 2022
Biosimilars
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of its bevacizumab biosimilar referencing Avastin, Vegzelma (CT-P16), from South Korea-headquartered Celltrion Healthcare. 25 June 2022
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) recommended seven novel medicines for approval at its June 2022 meeting, including the first gene therapy for hemophilia A. 24 June 2022
Biotechnology
Merck & Co today announced that the European Commission (EC) has approved Keytruda (pembrolizumab) Merck’s mega-blockbuster anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. 24 June 2022
Biotechnology
Shares of German biotech BioNTech closed up almost 7% at $132.29 yesterday, after the company – which burst on the scene with its hugely successful COVID-19 vaccine Comirnaty – announced a important development for its wider portfolio. 24 June 2022
Biotechnology
The European Medicines Agency (EMA) has recommended granting a marketing authorization for COVID-19 Vaccine (inactivated, adjuvanted) Valneva, developed by developed by French company Valneva, for use in the primary vaccination of people from 18 to 50 years of age. 23 June 2022
Biotechnology
Swiss pharma giant Novartis today announced that the European Commission (EC) approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 23 June 2022
Pharmaceutical
After repeated failures to register its Duchenne muscular dystrophy (DMD) drug in the USA, new data suggest PTC Therapeutics might be about ready to try again. 22 June 2022
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