Regulatory News ODAC reviews two longest-running accelerated approvals as FDA weighs using its new authority November 17, 2023Vol.49 No.43By Jacquelyn Cobb
Regulatory News ODAC vote on sotorasib signals FDA intent to confront perceived loss of equipoise in cancer clinical trials October 06, 2023Vol.49 No.37By Jacquelyn Cobb and Paul Goldberg
Regulatory News ODAC votes to recommend neuroblastoma drug for first-ever approval based on trial using external control arm October 06, 2023Vol.49 No.37By Jacquelyn Cobb and Paul Goldberg
Regulatory News ODAC says prostate cancer patients who lack proven BRCA mutation shouldn’t get PARP inhibitor May 05, 2023Vol.49 No.18By Paul Goldberg
Regulatory News Industry, FDA, Friends focus on data needed to speed up development of gene and cell therapies May 05, 2023Vol.49 No.18By Matthew Bin Han Ong
Conversation with The Cancer LetterRegulatory News FDA’s Fashoyin-Aje: Draft guidance on accelerated approval urges reliance on randomized controlled trials March 31, 2023Vol.49 No.13By Jacquelyn Cobb
Regulatory News Improving on R-CHOP, ODAC votes 11:2 to move Genentech’s Polivy to the first line in diffuse large B-cell lymphoma March 10, 2023Vol.49 No.10By Jacquelyn Cobb
Regulatory News ODAC gives thumbs-up to GSK plan to build on MSK rectal cancer study of dostarlimab that produced 100% response February 10, 2023Vol.49 No.06By Jacquelyn Cobb and Paul Goldberg
Regulatory News ODAC considers the first application based wholly on RWE methodology—and nixes it unanimously November 04, 2022Vol.48 No.40By Paul Goldberg
Regulatory News Pazdur at FDA-ASCO workshop: Failure to optimize the dose is akin to building a house on quicksand May 06, 2022Vol.48 No.18By Alice Tracey
