Drugs & Targets Six months after court-ordered deadline, FDA hasn’t ruled on major e-cigarette manufacturers’ product applications, advocates say March 11, 2022Vol.48 No.10
Drugs & Targets FDA grants Fast Track designation to IO-202, anti-LILRB4 myeloid checkpoint inhibitor for AML February 18, 2022Vol.48 No.07
Regulatory News In a 14:1 vote, ODAC nixes a PD-1 drug developed in China; data not generalizable to U.S. population February 11, 2022Vol.48 No.06By Paul Goldberg and Alice Tracey
Conversation with The Cancer LetterRegulatory News FDA says it had no input as companies developed checkpoint inhibitors in China February 04, 2022Vol.48 No.05By Paul Goldberg
Drugs & Targets FDA investigating possible increased risk of death with lymphoma drug Ukoniq February 04, 2022Vol.48 No.05
In Brief Robert Califf’s confirmation as FDA commissioner clears Senate HELP Committee January 14, 2022Vol.48 No.02
Drugs & Targets FDA grants fast track designation for enobosarm in AR+ ER+ HER2- metastatic breast cancer January 14, 2022Vol.48 No.02
Drugs & Targets FDA clears IND for P-MUC1C-ALLO1, a fully allogeneic CAR T targeting multiple solid tumors January 07, 2022Vol.48 No.01
Drugs & Targets FDA grants Breakthrough Therapy designation for CLN-081 in locally advanced or metastatic EGFR-mutated NSCLC January 07, 2022Vol.48 No.01