FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India ...

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 ...

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

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

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

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 U.S. Food & Drug Administration has confirmed that the multistate outbreak of Listeriosis linked to refrigerated and ...

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