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

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

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

The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary ...

The US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide ...

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 joint guidelines state that AI should be explainable and interpretable. Drug developers can no longer submit an ...

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.

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

Evolving FDA regulations pose real risks for unwary food brands, but those who proactively  invest in compliance can transform these challenges into opportunities.