Donanemab was approved by the FDA in July 2024 to treat adults with early symptomatic Alzheimer's disease with confirmed ...

The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of ...

Off-label use is the use of drugs in a manner that has not been approved by the regulatory agencies—the FDA in the United States. Specifically, off-label use can represent: (1) the use of a ...

Opinion: Orrick's Irena Royzman and Dana Sublett write that judges have done a good job in multiple decisions that protect ...

Food and Drug Administration, Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices (Washington, DC: FDA, December 2011).

One in five prescriptions is written for off-label use, according to a 2006 study in the Journal of the American Medical Association."In some cases, that off-label prescribing makes sense," says ...

About 12% of drugs doctors prescribe are for uses other than those approved by regulators, a recent study found. So-called off-label prescribing significantly raises the rate of negative side ...

An argument could be made — and frequently has been made — that the off-label use of certain drugs in certain situations is a good thing.. And, indeed, prescribing drugs off-label (for uses ...