On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific ...
Developers of a lab-grown blood vessel designed to save life and limb in emergency scenarios appear to be promoting its use in surgeries far beyond what the Food and Drug Administration has approved ...
Kos Pharmaceuticals, a subsidiary of Abbott Laboratories headquartered in North Chicago, Ill., has agreed to pay more than $41 million to resolve allegations involving two of its products, Advicor and ...
American company Eli Lilly said it does not endorse the off-label use of Mounjaro (tirzepatide) for cosmetic weight loss. “Patient safety is Lilly’s top priority, and Lilly ne ...
After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda Pharmaceuticals is pursuing a new route to establish the drug in the space. Hetlioz was ...
Off-label prescription of psychiatric drugs in the United States began to take off in the 1990s. Children and adolescents are ...
A new sociomedical perspective shows how off-label use of GLP-1 drugs for slimness is redefining what counts as a healthy, responsible body, revealing hidden moral pressures and global inequalities ...