The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...

The Food and Drug Administration turbulent leadership changes is allowing the Trump administration to loosen rules for vapes, ...

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer ...

The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with ...

The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs. “This draft guidance not only ...

The Trump administration is pivoting hard on vaping, taking down guardrails that have limited the industry’s growth in recent years and making clear the tobacco industry’s enduring influence over ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general wellness category and skip the agency's expensive review process before going to ...

Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.

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.

XanaMIA randomized, pivotal trial of oral Xanamem 10 mg fully enrolled and remains on track for topline final results in ...