EMA Regulatory News
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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
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
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
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
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