Drugs & Targets Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC September 27, 2024Vol.50 No.36
Regulatory News Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover designThe agency accepts the invitation September 20, 2024Vol.50 No.35By Paul Goldberg
Drugs & Targets FDA approves Keytruda + pemetrexed + chemo in first-line mesothelioma indication September 20, 2024Vol.50 No.35
Drugs & Targets FDA approves Rybrevant + pemetrexed + chemo in NSCLC with EGFR exon 19 deletions or L858R mutations September 20, 2024Vol.50 No.35
Drugs & Targets FDA approves Kisqali + aromatase inhibitor for early high-risk breast cancer September 20, 2024Vol.50 No.35
Drugs & Targets FDA grants Fast Track designation for ICT01 + Azacitidine + Venetoclax in treatment of first-line AML unfit for induction chemo September 20, 2024Vol.50 No.35
Drugs & Targets FDA issues draft guidance on conducting multiregional clinical trials in oncology September 20, 2024Vol.50 No.35
Drugs & Targets FDA issues guidance on implementing decentralized elements in clinical trials September 20, 2024Vol.50 No.35
Drugs & Targets FDA issues guidance on integrating randomized controlled trials into routine clinical practice September 20, 2024Vol.50 No.35
