European Union & United States — Food and Drug Administration
50 shared events · Importance 7 · Last updated Aug 21, 2026
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Domestic
European Union: The European Union>>> is a stakeholder and partner in launching the 'Choose Milk' campaign, contributing to nutrition awareness in Nigeria>>>.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> is a key institution participating in the 'Choose Milk' campaign to promote informed dietary choices.
May 26, 2026 · 6 articles
Regulatory
European Union: The EU is reviewing mFLUSIVA, which could expand Moderna's market access.
United States — Food and Drug Administration: The FDA granted approval for mFLUSIVA, marking a regulatory milestone and demonstrating its role in vaccine oversight despite internal controversies.
Aug 05, 2026 · 105 articles
Business
European Union: Venglustat is also under regulatory review in the European Union, indicating potential future market expansion for Sanofi.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted priority review to Sanofi's venglustat, indicating its potential to address an unmet medical need for type 3 Gaucher disease.
May 28, 2026 · 6 articles
Business
European Union: The European Union is a key market where Imlifidase is conditionally approved and where the PAES study was conducted, leading to the upcoming application for full marketing authorization.
United States — Food and Drug Administration: The United States — Food and Drug Administration accepted the Biologics License Application for imlifidase in February 2026, indicating potential future market expansion for the drug in the US.
May 27, 2026 · 6 articles
Business
European Union: The European Union represents a significant market where Dyne Therapeutics is seeking approval for zeleciment basivarsen, supported by the Orphan Drug designation from the European Union — European Medicines Agency.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is the regulatory body responsible for granting Accelerated Approval and Priority Review for zeleciment basivarsen, which is crucial for its potential U.S. launch. The FDA has already granted Breakthrough Therapy, Orphan Drug, and Fast Track designations to zeleciment basivarsen.
Jun 03, 2026 · 6 articles
Business
European Union: The European Union is mentioned as a region where Jyong Biotech holds invention patents for its drug candidates, indicating future market potential.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) approval is a critical milestone for Jyong Biotech's lead drug candidates, as it enables market access and sets a precedent for global regulatory pathways.
May 29, 2026 · 7 articles
Domestic
European Union: EU partnership supports NAFDAC's reforms and regulatory alignment.
United States — Food and Drug Administration: NAFDAC is the central entity; its transformation under Adeyeye's leadership is the focus of the award. The agency's improved regulatory status enhances its credibility and operational capacity.
Jul 08, 2026 · 6 articles
Tech
European Union: The International — European Commission>>>'s marketing authorization for HYMPAVZI>>> affects patients within the European Union>>>.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> granted the expanded approval for HYMPAVZI, validating its efficacy and safety for a broader patient population. This action reflects the agency's role in regulating and approving pharmaceutical products in the United States>>>.
Jun 08, 2026 · 7 articles
Regulatory
European Union: The EU is the region where DAYBU is now approved, covering 27 member states and providing a new treatment option for Rett syndrome patients.
United States — Food and Drug Administration: The FDA previously approved trofinetide in the US, establishing its efficacy and safety.
Aug 24, 2026 · 7 articles
Business
European Union: The European Union granted CE mark certification for Alturion, enabling its sale in Europe.
United States — Food and Drug Administration: The FDA granted 510(k) clearance for Alturion, allowing its sale in the United States.
Jul 08, 2026 · 7 articles
Tech
European Union: The BD BACTEC FXI Culture System previously received CE mark under the European Union's In Vitro Diagnostic Regulation, indicating its availability in Europe.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted 510(k) clearance to the BD BACTEC FXI Culture System, allowing its commercialization in the U.S. market.
Jun 03, 2026 · 8 articles
Regulatory
European Union: The Phase 2 study will enroll patients in Europe, and QRX003 has Orphan Drug Designation in the EU for Netherton Syndrome.
United States — Food and Drug Administration: The FDA cleared the IND application for QRX003, expressing no safety concerns. This regulatory action allows Quoin to proceed with clinical development.
Jul 09, 2026 · 7 articles
Tech
European Union: The European Union is a key market where AI Highlights is being launched under the MDR, providing regulatory approval that enables commercialization. This may strengthen CapsoVision's presence in the EU and contribute to regional healthcare innovation.
United States — Food and Drug Administration: The FDA has not cleared AI Highlights, so it is not available in the U.S. This regulatory gap limits CapsoVision's domestic market opportunity and may be viewed as a constraint on the product's full potential.
Aug 03, 2026 · 6 articles
Business
European Union: The European Union is a key licensed territory where YUVEZZI will be commercialized, representing a significant market for the product.
United States — Food and Drug Administration: The FDA's approval of YUVEZZI is a prerequisite for its U.S. commercialization and adds credibility to the product.
Aug 20, 2026 · 12 articles
Business
European Union: The EU is another major market for PentixaFor, with regulatory support from the EMA and a large patient population.
United States — Food and Drug Administration: The FDA granted Fast Track designation to PentixaFor, facilitating its development and regulatory review.
Jul 15, 2026 · 10 articles
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
Regulatory
European Union: The European Union>>> is a market where the European Union — European Medicines Agency>>> has validated a Marketing Authorization Application for AVT16 and AVT80.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted the Biologics License Application for AVT16, initiating the review process for this proposed interchangeable biosimilar.
Jun 08, 2026 · 11 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
Regulatory
European Union: The EU has already granted marketing authorization for CAM2029 (Oczyesa), providing a reference for the US review.
United States — Food and Drug Administration: The FDA accepted the resubmission for review and set a PDUFA date; its regulatory decision will determine market access for CAM2029 in the US.
Jul 17, 2026 · 6 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: The European Union has granted Orphan Drug Designation to tralesinidase alfa enzyme replacement therapy (TA-ERT), which could facilitate its approval and commercialization in Europe.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) has granted several designations to tralesinidase alfa enzyme replacement therapy (TA-ERT), indicating its potential importance and accelerating its development.
May 28, 2026 · 7 articles
Business
European Union: The EU granted Orphan Drug Designation for YA-101, providing incentives for development.
United States — Food and Drug Administration: The FDA granted Fast Track and Orphan Drug Designations to YA-101, facilitating its development.
Jul 28, 2026 · 6 articles
Business
European Union: Regulatory jurisdiction where EMA PRIME designation and Orphan Drug designation were granted.
United States — Food and Drug Administration: Granted Fast Track and Breakthrough Therapy designations to lacutamab, facilitating its development and review.
Aug 10, 2026 · 10 articles
Business
European Union: The EU is a region where Idefirix has conditional approval, contributing to the product's overall commercial base.
United States — Food and Drug Administration: The FDA's acceptance of the BLA and PDUFA date of December 19, 2026, are key upcoming regulatory milestones for GT Biopharma in the US market.
Aug 18, 2026 · 6 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
Business
European Union: The PLANET platform, central to DOSIsoft Theranostics, is CE marked, indicating compliance with European health, safety, and environmental protection standards.
United States — Food and Drug Administration: The PLANET platform, central to DOSIsoft Theranostics, is FDA 510(k) cleared, indicating regulatory approval for its use.
May 26, 2026 · 7 articles
Business
European Union: The facility will also meet EU standards, enabling access to European markets and enhancing the partnership's global reach.
United States — Food and Drug Administration: The new facility will be built to USFDA standards, ensuring regulatory compliance for the US market, which is critical for the partnership's success.
Aug 05, 2026 · 6 articles
Accidents
European Union: A spokesperson for the European Union>>> stated that the risk of an Ebola outbreak in Europe is 'very low', indicating monitoring of the situation but no immediate alarm for the region.
United States — Food and Drug Administration: The United States — Food and Drug Administration has approved Inmazeb, a combination of antibodies, to treat Zaire Ebolavirus infection, which Regeneron Pharmaceuticals has donated for potential use in the current outbreak.
May 18, 2026 · 505 articles
Business
European Union: The EU is mentioned as a region where WK Kellogg has already removed artificial ingredients, reflecting stricter regulatory standards that influence global practices.
United States — Food and Drug Administration: The FDA's allowance of voluntary labeling claims about absence of certified colors supports companies like WK Kellogg in marketing their products as free of artificial dyes.
Aug 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
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