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 ...

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 ...

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 ...

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 ...

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 ...