An ethics complaint leads to a resignation, and the agency shifts approval standards.

For the first time, patients with abnormal cells detected in their bone marrow have a treatment option before the condition ...

On this week’s episode of "The Readout LOUD," melodrama at the top of the FDA and the latest on the Pfizer-Novo Nordisk ...

In Episode 28, Miroslav Gasparek, Sensible; Lizzy Lawrence, STAT; and Joe Lewis, Deloitte, go behind the headlines.

The search continues for a new leader for the FDA’s Center for Drug Evaluation and Research after George Tidmarsh resigned on ...

WASHINGTON — The Trump administration’s deal to expand access to and lower the cost of weight loss drugs has left industry ...

The UK regulator is creating a new framework for how it will approve rare disease treatments, which it intends to publish in ...