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

The FDA’s May 2026 guidance on cell and gene therapies provides for CMC flexibilities while insisting on quality and ...

High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

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

The U.S. Food and Drug Administration (FDA) has finalized guidance on clinical investigations for psychedelic drugs, clarifying trial issues ...

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 ...

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 ...

FDA’s recently unveiled 2025 Human Foods Program guidance agenda offers a detailed view of the agency’s priorities for the year ahead. The document is non-binding, but provides critical insight into ...

The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials. The ...

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...