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
- FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.” - Mayo Clinic AI detects pancreatic cancer up to three years before diagnosis, validation study finds
- Mt. Sinai forms committee to probe Epstein links to breast center founder Eva Dubin, other faculty members
- ASCO & The Conquer Cancer Foundation announce merit awards
- CBER Director Vinay Prasad dared to “say no to drugs”
- By adding specialists to USPSTF, Kennedy would reshape the functioning and decisions of the influential health panel
Ransohoff: “The task force’s job is to describe the evidence fairly, and that’s done best with objective, detached methodologists”









