Drugs & Targets FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors April 12, 2024Vol.50 No.15
White House White House misses deadline to finalize FDA rule banning menthol cigarettes, prompting lawsuit from health groups April 05, 2024Vol.50 No.14By Jacquelyn Cobb
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
