Regulatory News ESMO publishes guidances on AI tools for clinicians, patients, and researchersSays one author: “We think there should be some degree of human oversight, otherwise, they can go completely rogue and nobody notices.” December 12, 2025Vol.51 No.45By Sara Willa Ernst
Regulatory News Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulationsBIO calls for the end of “constant turmoil,” urges the administration to “right the ship” December 05, 2025Vol.51 No.44By Paul Goldberg
Conversation with The Cancer LetterRegulatory News Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director November 14, 2025Vol.51 No.42By Paul Goldberg
Regulatory News FDA to remove black box warnings on hormone therapy for menopauseTrump-era “gold standard science” is not to be confused with gold standard of scientific evidence November 14, 2025Vol.51 No.42By Claire Marie Porter
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 November 07, 2025Vol.51 No.41By Claire Marie Porter and Paul Goldberg
Regulatory News Friends study points to ctDNA’s potential to serve as an intermediate endpoint in NSCLCctMoniTR project aims to improve efficiency in development of intermediate endpoints October 24, 2025Vol.51 No.39By Jacquelyn Cobb
Regulatory NewsTrials & Tribulations Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research October 17, 2025Vol.51 No.38By Edison T. Liu
News AnalysisRegulatory News How animal testing became a MAHA political wedge issueWhile cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough October 17, 2025Vol.51 No.38By Claire Marie Porter and Jacquelyn Cobb
News AnalysisRegulatory News Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autismExperts call the move “extremely premature” September 26, 2025Vol.51 No.35By Claire Marie Porter and Paul Goldberg
Regulatory News ODAC nixes GSK’s Blenrep myeloma regimens, citing ocular toxicity, dosing, applicability to U.S. population July 18, 2025Vol.51 No.28By Jacquelyn Cobb and Sara Willa Ernst
