Accelerated approval based on response rate is not appropriate for Genta's Genasense given the Bcl-2 inhibitor's failure to show a benefit on clinical outcomes in a randomized Phase III trial, FDA and members of its Oncologic Drugs Advisory Committee said during a Sept. 6 meeting

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials.