Law

In mid-November 2025, Congress introduced the Biomanufacturing Excellence Act of 2025 (H.R. 6089) to establish a dedicated national center aimed at strengthening U.S. capacity for biopharmaceutical …

On October 28, 2025, the State of Texas filed a complaint against Johnson & Johnson and Kenvue, Inc. (“Kenvue”)—formerly the consumer health division of Johnson & …

Since the year began, we have attempted to divine the new administration’s approach to regulating human cell and tissue products (“HCT/Ps”).[1] What we have found is …

In late September, the U.S. Food & Drug Administration (“FDA”) issued three draft guidances related to cell and gene therapy (“CGT”) products: (1) Innovative Designs for …

On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued numerous untitled letters as part of the agency’s …

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Late yesterday, FDA issued a press release warning that it would be sending “thousands of letters warning pharmaceutical companies to remove misleading ads and issue approximately …

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim …

ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human …

In Eye Therapeutics, LLC, v. Slayback Pharma, LLC., Appeal no. 2023-2173, (Fed. Cir., June 30, 2025), a panel of Judges Scarisi, Stoll and Tramto reversed a …