European Union — European Medicines Agency
Tracked across 14 events · 145 articles · First seen Feb 10, 2025 · Last active May 28, 2026
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Business
Impact: The European Union — European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent for chronic spontaneous urticaria (CSU) in the European Union.
Feb 24, 2026 · 8 articles
Tech
Impact: The European Union — European Medicines Agency has released detailed guidance on computerized systems and data management, stressing the importance of secure, attributable and contemporaneous records, which accelerates the move toward automation.
Apr 07, 2026 · 8 articles
Tech
Impact: The European Union — European Medicines Agency provides statistics on the prevalence of Dementia UK in Europe, underscoring the regional impact of the condition.
Jan 02, 2026 · 7 articles
Business
Norgine announced that its drug PEDMARQSI (sodium thiosulfate anhydrous) has been registered by the Australia — Therapeutic Goods Administration in Australia. This registration allows for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy…
Impact: The European Union — European Medicines Agency previously granted Paediatric Use Marketing Authorisation for PEDMARQSI in May 2023.
May 05, 2026 · 6 articles
Business
Photocure reported strong financial results for the first quarter of 2026, with Hexvix/Cysview revenues of NOK 139.0 million and total revenues of NOK 264.6 million. The company's adjusted EBITDA reached NOK 15.3 million. Key drivers…
Impact: The European Union — European Medicines Agency accepted the Marketing Authorization Application for Cevira, leading to milestone payments for Photocure.
May 07, 2026 · 6 articles
Business
Impact: The European Union — European Medicines Agency was mentioned in GSK plc's alleged false statements regarding its independent conclusion on the causal association between ranitidine therapy and cancer.
Feb 10, 2025 · 34 articles
Tech
Impact: The European Union — European Medicines Agency's Committee for Orphan Medicinal Products provided a positive opinion for Etavopivat, leading to its Orphan Drug designation by the International — European Commission.
Apr 20, 2026 · 7 articles
Business
Oryzon Genomics reported its financial results for the first quarter ended March 31, 2026, showing a net loss of $2.0 million and a cash position of $25.4 million. The company provided a corporate update highlighting…
Impact: The European Union — European Medicines Agency authorized Oryzon Genomics to initiate the IDEAL Phase II trial for iadademstat in essential thrombocythemia.
May 14, 2026 · 6 articles
Business
BeOne Medicines, a global oncology company, was named 'Outstanding Global Oncology Company of the Year' at the HKCT Business Awards 2026, organized by the Hong Kong Commercial Times. This award acknowledges BeOne Medicines' significant progress…
Impact: A marketing application for BeOne Medicines' Next-Generation BCL-2 Inhibitor has been submitted to the European Union — European Medicines Agency, and it sets manufacturing standards for BeOne Medicines' Suzhou facility.
May 11, 2026 · 6 articles
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European Union — European Medicines Agency accepted Marketing Authorization Asieris PharmaceuticalsPhotocure Q1 2026 Earnings Report
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European Union — European Medicines Agency authorized trial initiation Oryzon GenomicsOryzon Genomics Q1 2026...
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BeOne Medicines submitted marketing application European Union — European Medicines AgencyBeOne Medicines Wins HKCT...
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European Union — European Medicines Agency granted marketing authorisation NorgineNorgine PEDMARQSI TGA...
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