Drugs & Targets FDA grants accelerated approval to Epkinly for R/R DLBCL and high-grade B-cell lymphoma May 26, 2023Vol.49 No.21
Drugs & Targets FDA grants PYX-201 Orphan Drug Designation in pancreatic cancer May 12, 2023Vol.49 No.19
Regulatory News ODAC says prostate cancer patients who lack proven BRCA mutation shouldn’t get PARP inhibitor May 05, 2023Vol.49 No.18By Paul Goldberg
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Drugs & Targets FDA releases draft guidance on decentralized clinical trials May 05, 2023Vol.49 No.18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
