FDA approves a new cancer drug, Vidaza, and two sNDAs, without going to ODAC. A date with ODAC may signal a weak case for drug approval, recent approval data indicate.
Also in this 8-page issue: Cooperative groups tell Congress that NCI’s $115 million in support for adult cancer clinical trials is “chump change.” Trials would close faster, report results sooner, if funding were increased, regulatory issues streamlined.
Larry Norton wins ASCO’s Karnofsky award.
Funding opportunities listed.
May issue of Business & Regulatory Report, 8 additional pages, included.
Trending Stories
- From “default dead” to living the future of cancer care
As founding CEO of GitLab, I went “founder mode” on my osteosarcoma - Maura Gillison, who identified the role of HPV in head and neck cancer, changing the standard of care, dies at 61
- I grew up unhoused. Now, with support from ACS, I am an MD-PhD student focused on oncology
My mother instilled in me: “Never become a product of your circumstances.” - What happened at FDA? Replimune approval raises questions
- What are The CheckPoints movin’ and groovin’ to this summer?
Join the journal club with the best bops: We asked SITC’s 13-piece band of medical musicians for the top papers and songs of the summer - Senate passes stopgap bill that would ban OMB from finalizing rule that would politicize science
