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The FDA's Cardiovascular and Renal Drugs Advisory Committee voted to recommend approval of NitroMed's product candidate BiDil (isosorbide dinitrate/hydralazine HCl) for the treatment of heart failure in black patients.
Senesco Technologies has reported the results of a series of mouse experiments which compared the company's proprietary Factor 5A technology to two approved drugs: dexamethasone and Enbrel.
Advancis Pharmaceutical and Par Pharmaceutical have announced that the companies' Amoxicillin PULSYS Phase III clinical trial for the treatment of adults and adolescents with pharyngitis/tonsillitis due to Group A streptococcal infections (commonly referred to as strep throat) failed to achieve its desired microbiological and clinical endpoints.
MedImmune has announced that the primary objective was met in a Phase III study evaluating the immunogenicity of two different formulations of its live, attenuated intranasal influenza vaccine.
Join FDAnews June 21 for a 90-minute audioconference on "Secrets
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and Regulators." Two Washington insiders --Wayne Pines and John
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Analysis: Understand Failures, Exceptions and Nonconformances." A veteran
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Flamel Technologies has filed a patent application with the U.S. Patent and
Trademark Office regarding the combination of its proprietary formulation of
aspirin with a Cox-2 inhibitor, including both conventional and selective Cox-2s.