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
Drugs & Targets FDA grants first marketing authorization for DNA test to assess predisposition for dozens of cancer types October 06, 2023Vol.49 No.37
Drugs & Targets FDA grants priority review to odronextamab for R/R follicular lymphoma and R/R diffuse large B-cell lymphoma October 06, 2023Vol.49 No.37
Drugs & Targets FDA proposes rule aimed at ensuring safety and effectiveness of laboratory developed tests October 06, 2023Vol.49 No.37
Drugs & Targets FDA establishes pilot program to accelerate development of rare disease therapies October 06, 2023Vol.49 No.37
Capitol Hill Most NIH activities will cease immediately if government shuts down September 29, 2023Vol.49 No.36By Matthew Bin Han Ong
Drugs & Targets FDA clears automated assay to assess tumor progression in neuroendocrine cancer September 29, 2023Vol.49 No.36
Drugs & Targets Mythic Therapeutics receives FDA Fast Track designation for MYTX-011 in NSCLC with cMET overexpression September 29, 2023Vol.49 No.36
