Nicholas Jacobus

Incyte reports sustained 24-week efficacy and consistent safety data for Opzelura cream in moderate atopic dermatitis, supporting growing interest in nonsteroidal topical therapies for long-term disease control.

Zentails announced the first dosage of Azenosertib administered in its phase III Aspenova trial to test azenosertib vs chemotherapy in Cyclin E1-positive platinum-resistant ovarian cancer.

FDA clears Cellenkos’ IND for CK0802, enabling a mid-stage trial in steroid-refractory GVHD.

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

The company submitted the new dosage for approval based on its Phase III trial results.

Examine strategies for validating, monitoring, and safely deploying configurable AI agents to ensure compliance and performance in clinical trials.

Take a closer look at how agentic AI can automate repetitive monitoring tasks while keeping human oversight central to critical decision-making in clinical research.

Gain perspective on how agentic AI can bridge eCOA, EDC, IRT, and CTMS platforms to reduce manual effort and improve operational efficiency.

Understand how adaptive human-in-the-loop frameworks can maintain safety and decision quality as AI becomes more embedded in trial monitoring and data review.

Gain insight into how AI-powered agents can eliminate inefficiencies, shorten development timelines, and free clinical teams to focus on strategic decision-making.