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European Union › Regulatory Requirements › Regulatory Agencies

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated May 2, 2025

Rothwell, Figg, Ernst & Manbeck, P.C. on

FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more

A&O Shearman

RTS on criteria for the composition of joint examination teams under EU DORA published in OJ

A&O Shearman on

Commission Delegated Regulation 2025/420 has been published in the Official Journal of the EU. This Delegated Regulation supplements Regulation 2022/2554 on digital operational resilience for the financial sector (DORA)...more

Epiq

[Webinar] Trends in European Competition Law - November 4th, 4:00 pm GMT

Epiq on

Please join us for a panel discussion featuring Europe's leading experts on Antitrust/Competition Law. Key topics of discussion: - Regulatory Investigation Tools and Powers - The Rise of Dawn Raids - Digital...more

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