The FDA posted to its set a warning letter previously sent to Owens & Minor, Inc. dba American Contract Systems, following an inspection ...

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...

An ad-hoc analysis found a higher rate of severe and life-threatening infections in patients with RET-mutant lung cancer ...

There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in ...

However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...

Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...

Earlier this week, President-elect Donald Trump’s Justice Department transition team issued an ominous warning to all DOJ career attorneys: You risk losing your jobs if you resist the Trump agenda ...

Healthcare stocks performed well during Trump's first term, despite increased uninsured rates and reduced regulation. Click ...

The Food and Drug Administration on Wednesday warned nine online retailers and one manufacturer for selling or distributing ...

iRhythm Technologies has announced that the US Food and Drug Administration (FDA) has cleared design updates made to its Zio AT device. The Zio AI continuous monitoring system combines a wearable ...

The British Medical Association has warned Northern Ireland people not to view weight loss injections as ‘a quick fix’, and ...