United States & European Union — European Medicines Agency
27 shared events · Importance 4 · Last updated Aug 17, 2026
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United States: The United States is one of the countries where hantavirus patients are being treated.
European Union — European Medicines Agency: The European Union — European Medicines Agency identified favipiravir as the most plausible candidate for hantavirus treatment under clinical trial or compassionate use protocols.
May 28, 2026 · 6 articles
Regulatory
United States: The U.S. is a key market for the vaccine, with high Lyme disease incidence and a large at-risk population.
European Union — European Medicines Agency: The EMA is the regulatory body validating and assessing the application. Its decision will determine market access in Europe.
Aug 14, 2026 · 12 articles
Regulatory
United States: The U.S. is the primary market for the regulatory submission.
European Union — European Medicines Agency: The EMA is also reviewing the combination for the same indication.
Jul 22, 2026 · 6 articles
Business
United States: The United States is a key market for the potential launch of zeleciment basivarsen, with Dyne Therapeutics targeting U.S. Accelerated Approval and a U.S. launch in H1 2028.
European Union — European Medicines Agency: The European Union — European Medicines Agency (EMA) has granted Orphan Drug designation to zeleciment basivarsen, indicating Dyne Therapeutics' pursuit of approval pathways outside of the U.S.
Jun 03, 2026 · 6 articles
Business
United States: The US is a key market for PentixaFor, with an expanded patient pool due to new screening guidelines.
European Union — European Medicines Agency: The EMA granted PRIME status to PentixaFor, providing enhanced support for its development and approval in European Union — Europe.
Jul 15, 2026 · 10 articles
Regulatory
United States: The United States>>> is the market where the United States — Food and Drug Administration>>> accepted the BLA for AVT16, potentially expanding biosimilar options for patients and healthcare providers.
European Union — European Medicines Agency: The European Union — European Medicines Agency>>> has validated a Marketing Authorization Application for AVT16 and AVT80, indicating progress in European markets.
Jun 08, 2026 · 11 articles
Regulatory
United States: The United States is a target for a Biologics License Application (BLA) submission in early 2027 for INmune Bio Inc.'s CORDStrom platform, indicating future regulatory efforts in the country.
European Union — European Medicines Agency: 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
Regulatory
United States: Country where trofinetide is approved under the name DAYBUE, providing a reference for the EU approval.
European Union — European Medicines Agency: The EMA's advisory committee recommended approval, which preceded the International — European Commission's decision.
Aug 24, 2026 · 7 articles
Business
United States: The United States is highlighted as the largest pharmaceutical market globally, making it a key focus for EirGenix's expansion and partnership discussions.
European Union — European Medicines Agency: 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
Domestic
United States: The US has shifted toward a risk-based approach; Health Secretary Robert F. Kennedy Jr. has advocated stopping recommendations for children.
European Union — European Medicines Agency: EMA oversees vaccine safety in the EU and received confidential documents from BioNTech regarding adverse events, but the policy change is a national decision.
Jul 13, 2026 · 6 articles
Regulatory
United States: Jurisdiction where the FDA and courts are located; regulatory decisions affect patient access and market dynamics.
European Union — European Medicines Agency: Granted orphan drug designation; not directly involved in the FDA setback.
Jul 27, 2026 · 293 articles
Business
United States: The US represents a significant potential market for Idefirix, with FDA review ongoing and a decision expected in December 2026.
European Union — European Medicines Agency: The EMA's prior conditional approval and PRIME designation support Idefirix's regulatory standing in Europe, though not directly impacted by this event.
Aug 18, 2026 · 6 articles
Business
United States: The United States is one of the countries where Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel has been evaluated in clinical trials and where additional regulatory filings are planned.
European Union — European Medicines Agency: The European Union — European Medicines Agency has granted orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification, and priority medicines (PRIME) designation to Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel.
Jun 10, 2026 · 6 articles
Business
United States: Regulatory jurisdiction where FDA designations were granted and where commercialization rights are included.
European Union — European Medicines Agency: Granted PRIME designation for lacutamab in Sézary syndrome, supporting accelerated assessment.
Aug 10, 2026 · 10 articles
Business
United States: Country where Palsonify is approved and where most patients reside.
European Union — European Medicines Agency: Approved Palsonify for acromegaly in the EU.
Jul 06, 2026 · 34 articles
Business
United States: The United States is mentioned in the context of Oman's last bilateral agreement in 2006, providing historical context for Oman's trade policy.
European Union — European Medicines Agency: Indian generic medicines approved by the European Union — European Medicines Agency>>> will receive fast-track marketing authorization in Oman>>> under the CEPA.
May 29, 2026 · 79 articles
Business
United States: Ascentage Pharma has a U.S. presence and FDA clearances, but this event does not directly impact the country.
European Union — European Medicines Agency: The EMA has cleared several of Ascentage Pharma's Phase III trials, but this event does not directly involve the EMA.
Jul 26, 2026 · 6 articles
Business
United States: Cosmos Health is expanding in the US; the buyback is a corporate action with no direct impact on the country.
European Union — European Medicines Agency: The EMA certifies Cana Laboratories; the buyback has no direct impact on this relationship.
Jun 30, 2026 · 63 articles
Business
European Union — European Medicines Agency: 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
European Union — European Medicines Agency: The European Union — European Medicines Agency reviewed IDEFIRIX as part of its PRIority Medicines program, supporting its conditional marketing approval in Europe.
May 25, 2026 · 6 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency certifies Abbott Laboratories's manufacturing practices, ensuring compliance with European Good Manufacturing Practices.
Jun 18, 2026 · 7 articles
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