BiDil Endorsed By HFSA As Standard Therapy For Blacks With Heart Failure
This article was originally published in The Pink Sheet Daily
Executive Summary
Heart failure society’s guidelines also offer tempered recommendation of use for certain non-African-American patients.
You may also be interested in...
NitroMed's BiDil Approved For Heart Failure In Self-Identified Black Patients
The hydralazine/isosorbide dinitrate combination is the first approval for a race-based indication. In its recent review of BiDil, an FDA advisory committee suggested race was serving as a surrogate for genomic markers. FDA suggests further study could expand BiDil's approval beyond self-identified black patients.
Nexavar “Very Competitive” With Pfizer’s Sutent, Bayer Says
Bayer’s kidney cancer drug brought in $25.2 mil. (€20 mil.) in the first quarter following its approval late last year.
Nebivolol Approval Could Come In Mid-2007, Forest Says
The firm is conducting small studies of short duration after meeting with FDA regarding a May 2005 “approvable” letter.