Regulatory News Industry, FDA, Friends focus on data needed to speed up development of gene and cell therapies May 05, 2023Vol.49 No.18By Matthew Bin Han Ong
Trials & Tribulations Continuous temperature tracking helps manage infection risk after CAR T-cell therapy May 05, 2023Vol.49 No.18By Ruth Phillips
Drugs & Targets FDA approves xT CDx, an NGS-based in vitro diagnostic device May 05, 2023Vol.49 No.18
Drugs & Targets FDA releases draft guidance on decentralized clinical trials May 05, 2023Vol.49 No.18
Drugs & Targets FDA accepts sBLA and EMA validates Reblozyl as first-line treatment of anemia in lower risk MDS May 05, 2023Vol.49 No.18
Drugs & Targets FDA grants Fast Track designation for ¹⁷⁷Lu-PNT2002 for metastatic castration-resistant prostate cancer April 28, 2023Vol.49 No.17
Guest Editorial Mifepristone and the Administrative Procedure Act: Perspective of a former FDA commissioner and NCI director April 14, 2023Vol.49 No.15By Norman E. "Ned" Sharpless
Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment April 14, 2023Vol.49 No.15By Jacquelyn Cobb
Conversation with The Cancer LetterRegulatory News FDA’s Fashoyin-Aje: Draft guidance on accelerated approval urges reliance on randomized controlled trials March 31, 2023Vol.49 No.13By Jacquelyn Cobb
Drugs & Targets FDA grants full approval indication for Keytruda for certain patients with advanced MSI-H or dMMR solid tumors March 31, 2023Vol.49 No.13
