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
Drugs & Targets FDA approves Padcev + Keytruda for locally advanced or metastatic urothelial cancer January 05, 2024Vol.50 No.01
FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals December 15, 2023Vol.49 No.46By Matthew Bin Han Ong
Drugs & Targets FDA approves Iwilfin for adult and pediatric patients with high-risk neuroblastoma December 15, 2023Vol.49 No.46
As Bertagnolli steps in, NIH and FDA reenvision clinical trials and evidence generation December 08, 2023Vol.49 No.45By Matthew Bin Han Ong
Drugs & Targets FDA grants Fast Track designation to Alpha1H for non-muscle invasive bladder cancer December 08, 2023Vol.49 No.45
Clinical Roundup FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies December 01, 2023Vol.49 No.44
