European Union — European Medicines Agency & United States — Food and Drug Administration
22 shared events · Importance 18 · Last updated Jun 25, 2026
Live sentiment trends, interaction importance charts, and action volume tracking available on the
Ergen Dashboard
Tech
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration encourages the adoption of advanced manufacturing technologies and continuous production models, reinforcing the shift from reactive to proactive compliance strategies in the pharmaceutical industry.
Apr 07, 2026 · 8 articles
Regulatory
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee is convening a meeting to review Paragon Therapeutics' Biologics License Application for Deramiocel, which is a critical step in the regulatory approval process for the drug.
Jun 26, 2026 · 6 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency>>> is involved in the approval process for Imlifidase>>>, with a payment contingent on its filing acceptance.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted the Biologics License Application for imlifidase in the US, indicating future market potential outside the current deal.
May 19, 2026 · 7 articles
Tech
European Union — European Medicines Agency: The European Union — European Medicines Agency granted IBM System/4 Pi Orphan Drug designation, which can expedite its development and review process in Europe.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted IBM System/4 Pi Orphan Drug designation, which can expedite its development and review process.
Jun 24, 2026 · 6 articles
Regulatory
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.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) 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 United States. The FDA also granted Fast Track designation for XPro1595.
Jun 25, 2026 · 6 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency has granted zilganersen Orphan Drug designation for Alexander disease.
United States — Food and Drug Administration: The United States — Food and Drug Administration is currently reviewing zilganersen with a PDUFA action date of September 22, 2026, and has granted it Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations.
Jun 25, 2026 · 6 articles
Regulatory
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) has already approved Lerociclib, indicating its efficacy and safety profile, which supports its regulatory review in other regions.
Jun 26, 2026 · 8 articles
Business
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.
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned as a regulatory agency whose harmonized frameworks are streamlining biosimilar approval pathways, benefiting companies like EirGenix.
Jun 30, 2026 · 6 articles
Tech
European Union — European Medicines Agency: AnaCardio received positive scientific advice from the European Union — European Medicines Agency regarding the development path for AC01.
United States — Food and Drug Administration: AnaCardio received positive scientific advice from the United States — Food and Drug Administration regarding the development path for AC01.
Jun 24, 2026 · 12 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'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
NEWSDESK
Explore this relationship live
Track how European Union — European Medicines Agency and United States — Food and Drug Administration interact across events, view sentiment trends, and discover connected entities.
Open Dashboard