European Union & United States — Food and Drug Administration
16 shared events · Importance 17 · Last updated Jun 25, 2026
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Regulatory
European Union: The European Union is a target for a Marketing Authorization Application (MAA) in 2026 for INmune Bio Inc.'s CORDStrom platform, indicating future regulatory efforts in the region.
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: The European Union>>> is a key region where SERB Pharmaceuticals>>> will acquire rights to Imlifidase>>>.
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
Business
European Union: The acquired manufacturing platform supplies into multiple global markets including the European Union, indicating its international reach.
United States — Food and Drug Administration: The acquired facilities have completed multiple United States — Food and Drug Administration inspections with clean results, indicating compliance with regulatory standards.
Jul 02, 2026 · 7 articles
Tech
European Union: A patent for Catheter Precision's Vivo technology was issued for European coverage, expanding the company's intellectual property protection in the European market.
United States — Food and Drug Administration: The United States — Food and Drug Administration previously granted marketing clearance for Catheter Precision's Vivo technology, indicating its regulatory approval in the US.
Jul 06, 2026 · 6 articles
International
European Union: Regulatory approval for Remplir in the European Union is expected in late 2026.
United States — Food and Drug Administration: The United States — Food and Drug Administration cleared Remplir for use in April 2025, which is a significant regulatory milestone for the device.
Jun 29, 2026 · 6 articles
NEWSDESK
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