Best Practices for Quality Control and Implementation of Single-Use Systems By Jerold Martin

New data show risk-based and centralized monitoring shifts effort across roles, sites, and timelines, reshaping how sponsors plan CRA capacity needs.

NouvSight001 isn't limited to the RPE65-mutation subset current gene therapy treats, potentially reaching more of the 1.5 million with RP worldwide.

FDA's new rule formally recognizes non-animal methods like organoids and AI models as valid ways to support human drug testing.

Novo Nordisk reports that CagriSema outperformed tirzepatide with 12.4% weight loss versus 9.1% in a phase 3 trial in adults with type 2 diabetes.

FDA compliance officers detailed 2026 guidance updates, online drug sale enforcement, and a first-of-its-kind AI-related warning letter at the PDA/FDA Joint Regulatory Conference.

More than half of patients achieved clear or almost clear hands and feet with lebrikizumab by week 16, and 77% reported satisfaction with clearance.

Updated 36-month data in 15 high-dose patients showed 80% slowing on cUHDRS, while the 48-month cUHDRS result did not reach statistical significance. uniQure attributes the gap to attrition in the external control, and the FDA is reviewing a BLA based on the 36-month data.

Daiichi Sankyo and Merck pulled ifinatamab deruxtecan's FDA filing in small cell lung cancer after a 187-patient trial fell short.