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 ...

A 2020 Pandemic Note: The underlying study and preparation of this report began in September 2019 when global socio-economic conditions were much different from today. While the average annual ...