A promising new therapy, the FDA approval of Lipfendra, and updated cholesterol guidelines are expanding treatment options ...

The FDA proposed a new rule on Monday calling for food companies to disclose the addition of new ingredients in their ...

A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...

On July 13, 2026, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its guidance on “Psychedelic Drugs: Considerations for ...

The 2026 proposal is seemingly shifting the TRT landscape, moving it further from the "use with caution" territory.

The FDA has published guidance with information for manufacturers and processors of ready-to-eat produce to help them comply with federal law. The guidance is non-binding and does not carry the force ...

The US Food and Drug Administration (FDA) has published two guidances on transdermal or topical delivery systems (TDS) for generic drugs, including a final guidance on assessing adhesives for TDS ...

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...

The FDA panel is reviewing seven peptides and deciding if they should be added to a list of substances that can be safely ...