Regulatory News

ESMO publishes guidances on AI tools for clinicians, patients, and researchers
Regulatory News

ESMO publishes guidances on AI tools for clinicians, patients, and researchers
Says one author: “We think there should be some degree of human oversight, otherwise, they can go completely rogue and nobody notices.”

The European Society For Medical Oncology has formally weighed in on a question that U.S. medical groups have been chipping away at as well: How can we guarantee safe and effective use of artificial intelligence in oncology?
CDER Director Tidmarsh quits amid inspector general probe of his “personal conduct”
Regulatory News

CDER Director Tidmarsh quits amid inspector general probe of his “personal conduct”
Cancer advocates express concern about comments that signal trouble for accelerated approval

George F. Tidmarsh has resigned from his job as director of the FDA Center for Drug Evaluation and Research in the aftermath of a lawsuit by a former associate and a probe into what an HHS spokesperson described as “serious concerns about his personal conduct.”
Friends study points to ctDNA’s potential to serve as an intermediate endpoint in NSCLC
Regulatory News

Friends study points to ctDNA’s potential to serve as an intermediate endpoint in NSCLC
ctMoniTR project aims to improve efficiency in development of intermediate endpoints

New research led by Friends of Cancer Research demonstrates that decreases in circulating tumor DNA after initiation of treatment are associated with improved overall survival in patients with advanced non-small cell lung cancer treated with immunotherapy or chemotherapy.
Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research
Regulatory NewsTrials & Tribulations

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL).