Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more
On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more
I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
On October 22, Novo Nordisk (Novo) nominated semaglutide products, which include its popular drugs marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management, for inclusion on FDA's Demonstrable...more
Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more
The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in...more
We have all been there: An advertisement on television or a pop-up on Facebook beckons us to try the latest “visit-free,” “delivered to your door” treatment for a medical condition. Originally published in Dermatology Times...more
IDENIX PHARMACEUTICALS LLC v. GILEAD SCIENCES INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of Delaware. Summary: Synthesizing and screening tens of thousands of...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more
Artificial Intelligence (AI) inventions have aided development in nearly every industry, but perhaps none more so than synthetic biology. For synthetic biology researchers, AI has developed into a vital tool to create cutting...more