Drugs & Targets FDA approves nivolumab for adjuvant treatment of stage 2B/C melanoma October 20, 2023Vol.49 No.39
In Brief Julie Beitz named principal drug regulatory expert at Hyman, Phelps & McNamara October 13, 2023Vol.49 No.38
Drugs & Targets FDA approves encorafenib with binimetinib for metastatic NSCLC with a BRAF V600E mutation October 13, 2023Vol.49 No.38
Real-world Evidence Real-world tumor response rate can serve as a clinical endpoint, Friends pilot study showsFDA says raw images enrich the data when used with clinician assessments October 06, 2023Vol.49 No.37By Matthew Bin Han Ong
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
