Drugs & Targets FDA releases draft guidance aimed at improving oncology clinical trials for accelerated approval March 24, 2023Vol.49 No.12
Drugs & Targets FDA grants accelerated approval to Zynyz for metastatic or recurrent locally advanced Merkel cell carcinoma March 24, 2023Vol.49 No.12
Drugs & Targets FDA approves Tafinlar + Mekinist for pediatric patients with low-grade glioma with a BRAF V600E mutation March 17, 2023Vol.49 No.11
Regulatory News Improving on R-CHOP, ODAC votes 11:2 to move Genentech’s Polivy to the first line in diffuse large B-cell lymphoma March 10, 2023Vol.49 No.10By Jacquelyn Cobb
Drugs & Targets FDA broadens indication for Verzenio in HR+, HER2-, node-positive, high-risk early breast cancer March 10, 2023Vol.49 No.10
Drugs & Targets FDA approves label expansion for VENTANA PD-L1 assay to identify patients with locally advanced and metastatic NSCLC eligible for Libtayo March 10, 2023Vol.49 No.10
Drugs & Targets FDA updates mammography regulations to require reporting of breast density information and enhance facility oversight March 10, 2023Vol.49 No.10
In Brief FDA’s Center for Tobacco Products outlines steps to strengthen tobacco program March 03, 2023Vol.49 No.09
Regulatory News ODAC gives thumbs-up to GSK plan to build on MSK rectal cancer study of dostarlimab that produced 100% response February 10, 2023Vol.49 No.06By Jacquelyn Cobb and Paul Goldberg
