Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one ...

A key advantage of using RWD in a natural history study is gaining diverse and representative data. RWD covers broad patient populations, including those with comorbidities, various age groups, and ...

“Designing treatments unique to individual patients has always been the promised goal of personalized medicine. After 25 years the FDA has, for the first time, outlined a framework to facilitate these ...

PEACE-2 finds adding cabazitaxel to ADT plus radiotherapy fails to improve survival in high-risk localized prostate cancer, while increasing severe toxicities and deaths.

Held Type A meeting with FDA to discuss AMT-130 for Huntington’s disease; Company evaluating Phase III development considerations and plans to request follow-up Type B meeting in the second quarter of ...

TD Cowen 46th Annual Health Care Conference March 2, 2026 10:30 AM ESTCompany ParticipantsBrett Monia - Founder, ...