United States: Food and Drugs Law

In May 2024, FDA finalized a rule regarding LDTs, which purported to amend the 21 CFR 809.3(a) definition of "in vitro diagnostic products"...

On April 2, 2025, in a significant decision in FDA v. Wages and White Lion Investments, LLC, the Supreme Court unanimously upheld the Food and Drug Administration's (FDA) decision denying marketing authorization for certain e-cigarette products.

On April 16, Arkansas Governor Sarah Huckabee Sanders signed into law HB1150 and HB1531, two significant pieces of legislation affecting pharmacy benefit managers...

In May 2024, FDA finalized a rule regarding LDTs, which purported to amend the 21 CFR 809.3(a) definition of "in vitro diagnostic products"...

On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice...

The National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, "urging Congressional action...

The members of BakerHostetler's Antitrust and Competition Team are pleased to present these brief updates from the conference sessions on Day 2 at this week's ABA Antitrust Spring Meeting...

On 4 April 2025, Washington became the first state to enact a broad, industry-agnostic merger control regime.

On April 2, 2025, in a significant decision in FDA v. Wages and White Lion Investments, LLC, the Supreme Court unanimously upheld the Food and Drug Administration's (FDA) decision denying marketing authorization for certain e-cigarette products.

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations.

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101.

GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech's Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents.