The Food and Drug Administration on Thursday approved a core component of a brain implant made by Precision Neuroscience, a ...

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...

Sanofi and Regeneron's fully human monoclonal antibody Dupixent (dupilumab) has gained approval from the US Food and Drug ...

In an interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary introduced a new mechanism-driven ...

The lower number of reported decisions is occurring despite more pending applications for these high-risk devices.

In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER ...

The FDA announced it will be reducing, refining and potentially replacing the animal testing requirement for the approval of ...

One of the FDA’s recently departed top ... at the agency and how they could imperil the drug approval process that has served as the global regulatory standard for decades.

Atai's financial resources appear sufficient to fund key milestones into late 2026, but future funding needs and potential ...

Rare diseases, often referred to as orphan diseases, affect small patient populations, yet collectively they impact more than ...

The FDA clearance centers on the Layer 7 Cortical Interface, a wafer-thin, flexible electrode array designed to rest on the ...

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) for the treatment of chronic spontaneous ...