ImmunityBio's ANKTIVA sBLA for papillary bladder cancer was rejected by the FDA despite prior support, prompting the company to request urgent talks.

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant ...

The idea of a purge followed by a blender is new, but the idea of a ‘supercenter’ isn’t. Back in 1982, FDA’s Bureau of Drugs ...

In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions ...