New Drug Application (NDA)
New Drug Application (NDA) for Rasilez(R) (aliskiren), an Innovative Oral Renin Inhibitor to Treat High Blood Pressure, (SYS-CON Media)
-- NDA includes data from more than 6,000 people on Rasilez in 34 trials. Clinical trials showed that when used alone Rasilez produced significant blood pressure reductions sustained over 24 hours
LILLY (ELI) & COMPANY: Lilly Reports Q1 EPS Earnings (FinanzNachrichten)
Date: April 20, 2006 For Release: Immediately Refer to: (317) 276-5795 - Terra Fox Lilly Reports Q1 EPS of $.77, or 13% Growth Company Also Announces Arxxant's Receipt of Priority Review Status by FDA Eli Lilly ( Nachrichten / Aktienkurs ) and Company (NYSE: LLY) announced financial results for the first quarter of 2006.
BioSante Pharmaceuticals Announces FDA Filing and Review of NDA for Bio-E-Gel(R) (Business Wire via Yahoo! Finance)
LINCOLNSHIRE, Ill.----April 19, 2006--BioSante Pharmaceuticals, Inc. announced today that its new drug application for Bio-E-Gel , an innovative low-dose topical therapy for moderate-to-severe hot flashes in menopausal women, has been accepted for filing and review by the U.S.
Chembio Receives FDA Approvable Letter for Its Rapid HIV Tests; Major Hurdle for U.S. Sales and Eventual Over the (RedNova)
Chembio Diagnostics, Inc. (OTCBB:CEMI) has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for its SURE CHECK(R) HIV 1/2 and HIV 1/2 STAT-PAK(TM) rapid test Pre-Market Applications (PMAs).