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New Regulations FDA Approval

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Venable LLP

May 2025 Stelara® and Humira® Interchangeable Biosimilar Approvals

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In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...more

Akin Gump Strauss Hauer & Feld LLP

FDA Grants Three Natural Food Additive Petitions

On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last...more

King & Spalding

EPA Issues New Waste Rules for Hospitals, Medical Clinics and Pharmacies

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The U.S. Environmental Protection Agency (“EPA”) recently issued new regulations for managing pharmaceutical waste under the Resource Conservation and Recovery Act (“RCRA”). The rules specify new requirements for hazardous...more

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