Law

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 …

In an interesting and somewhat unexpected turnabout over the last six months, FDA has pivoted its focus from regulating industry’s use of artificial intelligence (“AI”) to …

Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus …

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena …

In Sigray, Inc, v. Carl Zeis X-Ray [“Zeiss”], appeal 2023-2211 (Fed. Cir., May 23, 2025), the panel reviewed the Board’s decision in an IPR in which …

This week, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) posted a warning letter (the “Letter”)[1], issued on May 29, 2025, …

The central theme in this interference decision involving U.S. Pat. No. 8,697,359 is the amount and type of evidence required to support the conception of an …

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a …