Regulatory News Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials March 29, 2024Vol.50 No.13By Paul Goldberg
Regulatory News ODAC votes in favor of two CAR T-cell therapies for MM after weighing FDA concerns about early deaths March 22, 2024Vol.50 No.12By Jacquelyn Cobb and Paul Goldberg
Conversation with The Cancer LetterRegulatory News FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLCPooled analysis finds correlations between early endpoints and OS in ICI trials March 15, 2024Vol.50 No.11By Matthew Bin Han Ong and Paul Goldberg
Regulatory News ODAC gives thumbs-up to imetelstat for MDS, upholding the value of transfusion independence March 15, 2024Vol.50 No.11By Jacquelyn Cobb and Paul Goldberg
Regulatory News FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies February 02, 2024Vol.50 No.05By Alexandria Carolan
Regulatory News Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approvalMeanwhile, NCI trial will assess clinical utility January 12, 2024Vol.50 No.02By Jacquelyn Cobb
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
