European Union — European Medicines Agency
Tracked across 27 events · 208 articles · First seen Feb 10, 2025 · Last active Jul 05, 2026
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Regulatory
Impact: The European Union — European Medicines Agency's CHMP recommended the revocation of the marketing authorization for TAVNEOS, impacting its availability in the EU.
Jun 26, 2026 · 9 articles
Regulatory
Impact: The European Union — European Medicines Agency (EMA) is the overarching regulatory body whose CHMP adopted the positive opinion for DAYBU, facilitating its potential market entry in the EU.
Jun 26, 2026 · 6 articles
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
Regulatory
Impact: The European Union — European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on Omeros Corporation's drug narsoplimab, directly causing the company's stock price drop and triggering the subsequent investigation.
Jul 01, 2026 · 6 articles
Business
Impact: The European Union — European Medicines Agency>>> is involved in the approval process for Imlifidase>>>, with a payment contingent on its filing acceptance.
May 19, 2026 · 7 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
Tech
Impact: The European Union — European Medicines Agency granted IBM System/4 Pi Orphan Drug designation, which can expedite its development and review process in Europe.
Jun 24, 2026 · 6 articles
Regulatory
Impact: The European Union — European Medicines Agency (EMA) is mentioned as a target for a Marketing Authorization Application (MAA) in 2026 for INmune Bio Inc.'s CORDStrom platform, indicating future regulatory efforts in the European Union.
Jun 25, 2026 · 6 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
Impact: The European Union — European Medicines Agency has granted zilganersen Orphan Drug designation for Alexander disease.
Jun 25, 2026 · 6 articles
Regulatory
Impact: The European Union — European Medicines Agency (EMA) is currently reviewing Lerociclib for regulatory approval, which could expand its market reach beyond the United States and China.
Jun 26, 2026 · 8 articles
Regulatory
Impact: The European Union — European Medicines Agency has granted Orphan Drug Designation and Advanced Therapy Medicinal Product designation to Deramiocel, indicating its potential importance in Europe, though the current event focuses on U.S. regulatory review.
Jun 26, 2026 · 6 articles
Business
Impact: The European Union — European Medicines Agency is mentioned as a regulatory agency whose harmonized frameworks are streamlining biosimilar approval pathways, benefiting companies like EirGenix.
Jun 30, 2026 · 6 articles
Tech
Impact: AnaCardio received positive scientific advice from the European Union — European Medicines Agency regarding the development path for AC01.
Jun 24, 2026 · 12 articles
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European Union — European Medicines Agency recommended revocation CSL LimitedEU Revokes TAVNEOS...
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European Union — European Medicines Agency adopted negative opinion Omeros CorporationPomerantz Investigates...
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European Union — European Medicines Agency granted Orphan Drug IBM System/4 PiAL-S Pharma AP-101 Phase 2 Success
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European Union — European Medicines Agency granted designation Ionis PharmaceuticalsIonis, Recordati License...
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European Union — European Medicines Agency provided scientific advice AnaCardioAnaCardio AC01 GOAL-HF1...
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European Union — European Medicines Agency recommended medicinesAI Stock Sell-off, Iran War
United Kingdom — Medicines and Healthcare products Regulatory Agency
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European Union — European Medicines Agency
United Kingdom — Medicines and Healthcare products Regulatory Agency
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European Union — European Medicines Agency
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