May 24, 2024 — At a hearing this week fo the U.S. House Committee on Energy and Commerce, Representative Robin Kelly asked the Director of the FDA Center for Drug Evaluation and Research, Patrizia Cavazzoni, what the agency is doing to ensure that drug labeling adequately protects the safety of people with obesity: “Patients with obesity are frequently excluded […]
November 20, 2023 — FDA has a bone to pick with Otsuka, the company that sells Rexulti (brexpiprazole). The agency is taking issue with false advertising by the company for this drug used in schizophrenia and severe depression. To us, this problem of inflated efficacy claims is especially noteworthy because, for people with obesity who may need this drug, […]
November 12, 2023 — For some time to come, we will be learning more and more about the details and implications of the landmark SELECT study published yesterday in NEJM and presented at the American Heart Association Scientific Sessions in Philadelphia. A massive crowd packed the meeting hall yesterday for good reason. These results will change the practice of […]
