The company based in Lexington County received its inspection report back from federal regulators. Here's what it showed.

Shares of Alvotech (NASDAQ: ALVO) fell 22% on Monday after the U.S. Food and Drug Administration (FDA) issued a Complete ...

The notice follows inspections of three Philips facilities that found failures to meet standards for reporting complaints and ...

While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in ...

Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing ...

The Food and Drug Administration has advanced an investigation into one Salmonella outbreak and declared another one over.

If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of news coverage since late October 2025 ...

Federal health officials report two more deaths from a listeria outbreak connected to pasta in prepared meals, with recalls expanding nationwide.

The agency’s decision to conceal drug names on inspection reports has prevented doctors, pharmacists and patients from ...

Kemwell’s FDA-approved site features single-use and stainless-steel bioreactors, with over 5000L+ of installed upstream capacity, commercial fill-finish lines for liquid and lyophilized vials, and pre ...

In a letter to Philips’ CEO, the FDA cited quality system issues at three of Philips’ manufacturing sites, and failures over complaints handling.