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News about "European Union"
EU Approves Insmed's BRINSUPRI, the First Treatment for Non-CF Bronchiectasis
The European Commission has approved BRINSUPRI as the first treatment for Non-Cystic Fibrosis Bronchiectasis, offering a new option for patients with this serious, progressive lung disease. The first-in-class DPP1 inhibitor was granted accelerated assessment by the EMA, reflecting its significant public health importance.
European Union | 19/11/2025 | By Dineshwori | 144
EMA Recommends EU Approval for Waskyra to Treat Wiskott-Aldrich Syndrome
The EMA has recommended EU marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for patients aged six months and older with Wiskott-Aldrich Syndrome (WAS). The treatment uses a patient’s own modified stem cells to restore functional WAS protein.
European Union | 17/11/2025 | By Dineshwori | 103
EU Approves KEYTRUDA for PD-L1+ Resectable Head and Neck Cancer
KEYTRUDA monotherapy has been approved for use as a neoadjuvant treatment, followed by adjuvant therapy in combination with radiotherapy with or without cisplatin, and continued thereafter as maintenance monotherapy.
European Union | 30/10/2025 | By Dineshwori | 114
Dr. Reddy's Receives Positive CHMP Opinion from European Medicines Agency for Denosumab
Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar to Prolia and Xgeva, moving it closer to potential marketing authorisation in the European Economic Area (EEA).
European Union | 24/09/2025 | By Dineshwori | 107
CHMP Recommends T-DXd EU Approval in HER2-Low/Ultralow Breast Cancer
ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
European Union | 04/03/2025 | By Aishwarya | 217
Bio-Thera's BAT2506 Biosimilar to Simponi Gains EMA Review for EU Approval
The reference medicine golimumab has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.
European Union | 07/02/2025 | By Abha | 392
Evergreen Theragnostics Opens Phase II Small Cell Lung Cancer Clinical Trial in EU
The CCK2-VIEW trial uses 68Ga-EVG321, a peptide-based Radioligand imaging agent administered to patients with small cell lung cancer.
European Union | 18/10/2024 | By Aishwarya | 479
Union Health Secretary Explores Vaccine Collaboration at Bilthoven Biologicals in Netherlands
The focus centered on enhancing partnership and cooperation in the production of vaccines, addressing critical issues related to pandemic preparedness.
European Union | 29/04/2024 | By Abha | 325
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