Regulatory News Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again) March 13, 2026Vol.52 No.10By Claire Marie Porter
Regulatory News Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncologyAtara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.” March 13, 2026Vol.52 No.10By Jacquelyn Cobb
Cancer Policy FDA approves leucovorin for cerebral folate deficiency March 13, 2026Vol.52 No.10By Claire Marie Porter
Drugs & Targets FDA approves teclistamab + daratumumab hyaluronidase-fihj for r/r MM March 06, 2026Vol.52 No.09
Drugs & Targets FDA grants tentative approval for Lutetium Lu 177 dotatate March 06, 2026Vol.52 No.09
Cancer Policy FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases February 27, 2026Vol.52 No.08
Drugs & Targets FDA approves Braftovi combination regimen in first-line metastatic colorectal cancer February 27, 2026Vol.52 No.08
Drugs & Targets FDA approves Hernexeos as an initial treatment for HER2-mutant advanced NSCLC February 27, 2026Vol.52 No.08
Cancer Policy At Friends meeting, Pazdur, Woodcock lament FDA’s failure to protect the agency staff from political interference, warn of “lasting implications” February 20, 2026Vol.52 No.07By Jacquelyn Cobb and Claire Marie Porter
