It seemed like only a matter of time before someone would close this valve. After months of off-label prescribing of Ozempic, propelled by celebrity hype of the diabetes drug which has gained ...

Opinion: Generic drug manufacturers should view the Supreme Court's ruling in Hikma v. Amarin as a limited safe harbor ...

The US Food and Drug Administration (FDA) finalized guidance to industry on allowable communications to health care providers about off-label drug and device uses. The Q&A document, issued on 6 ...

When a clinician prescribes a medication for a purpose for which it’s not indicated by the U.S. Food and Drug Administration (FDA), it’s referred to as off-label treatment. Doctors may recommend ...

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 ...

With the off-label/intended use controversy still simmering, a bill has debuted in the U.S. House of Representatives that would restrict the federal government's ability to pursue charges against ...

The largest published prospective evaluation of off-label targeted cancer therapies has shown that more patients could benefit from existing drugs. After including over 1,600 patients in the Dutch ...

Pediatric patients are at increased risk of exposure to potentially harmful excipients when receiving off-label medicinal products primarily formulated for adults, raising concerns about adverse ...