FreeTrials & Tribulations Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization” January 27, 2023Vol.49 No.04By Mark J. Ratain and Garth W. Strohbehn
In Brief Grassley, Durbin, Tillis, Coons introduce legislation to strengthen coordination between Patent Office, FDA January 27, 2023Vol.49 No.04
Guest Editorial ODAC Confidential: The seven deadly sins sponsors commit again and again at FDA presentations January 20, 2023Vol.49 No.03By Mikkael A. Sekeres
Drugs & Targets Tukysa + trastuzumab receives FDA accelerated approval for previously treated metastatic CRC January 20, 2023Vol.49 No.03
Drugs & Targets FDA publishes draft guidance on optimizing dosage for oncology drugs January 20, 2023Vol.49 No.03
Drugs & Targets FDA grants accelerated approval to Lunsumio for R/R follicular lymphoma January 06, 2023Vol.49 No.01
Drugs & Targets FDA approves first gene therapy for high-risk, non-muscle-invasive bladder cancer January 06, 2023Vol.49 No.01