News & Analysis as of

Administrative Law Judge (ALJ) Food and Drug Administration (FDA) Appeals

McDermott Will & Emery

Federal Court Strikes Down LDT Final Rule

On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2023 ITC Section 337 Year in Review: Analysis & Trends: The Public Interest Impact – Considerations from AliveCor and Masimo

The year 2023 was marked by two landmark Commission determinations resulting in exclusion orders and cease and desist orders against a popular consumer wearable—the Apple Watch. both investigations focused on health...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - January 2024

WilmerHale on

Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision.  On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more

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