US FDA Commissioner Robert Califf held court with global regulators to discuss the overall state of real-world evidence and how different agencies across the world view it.

A leadership transition in FDA’s Office of Immunology & Inflammation will elevate former rheumatology division Director Nikolay Nikolov to the top spot – with a number of interim and inexperienced leaders in the management layers below.

The long-talked about wave of gene therapy approvals is beginning to reveal itself.

A case involving a tax that was an “exceedingly heavy burden” and played into the Supreme Court’s original ruling on the ACA could reemerge once the IRA challenge reaches the high court.

Although the advisory committee was uncomfortable with the external control, US FDA was reassuring over the approach – which eventually secured a ‘yes’ vote from the panel on palovarotene for FOP.

As US FDA offers initial issues for industry consideration, Senate majority leader outlines framework and process of a bipartisan effort to construct the ‘first of its kind’ legislation to regulate AI.