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
Regulatory News In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.” June 13, 2025Vol.51 No.23By Jacquelyn Cobb
Regulatory News ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session May 23, 2025Vol.51 No.20By Jacquelyn Cobb
