NitroMed BiDil for heart failure
FDA's Cardiovascular & Renal Drugs Advisory Committee will meet June 16 to evaluate NitroMed's BiDil for treatment of heart failure in African-Americans. NitroMed resubmitted the BiDil NDA with new data from the African American Heart Failure Trial (A-HeFT) in December; the user fee deadline is June 23. On June 15, the committee will discuss class labeling for antihypertensive drugs based on the proximity of their data to outcome trials. The meeting will be held at the Holiday Inn in Gaithersburg, Md. beginning at 8 a.m. on both days. [Editor's note: To 1watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...
You may also be interested in...
Illumina announced on 21 September it will buy back Grail, which is planning to commercialize its multi-cancer early detection blood test Galleri in 2021. See what Illumina’s CEO Francis deSouza said about it here.
Yes, Gottlieb’s in there twice; things get complicated when an agency starts to lose credibility.
Newly published data and results presented at ESMO for Amgen’s sotorasib (AMG 510) show relatively long-lasting responses and progression-free survival in lung cancer.