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
Drugs & Targets FDA approves Elahere for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer March 29, 2024Vol.50 No.13
Drugs & Targets FDA grants orphan drug designation to Heidelberg Pharma agent for MM March 29, 2024Vol.50 No.13
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
Drugs & Targets FDA grants accelerated approval to Iclusig + chemotherapy for newly diagnosed Ph+ ALL March 22, 2024Vol.50 No.12
Drugs & Targets FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products March 22, 2024Vol.50 No.12
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
Drugs & Targets FDA approves Breyanzi CAR T-cell therapy in adults with R/R/ CLL or SLL March 15, 2024Vol.50 No.11
