U.S. Food and Drug Administration

U.S. Food and Drug Administration Articles

Dendreon (DNDN-NASDAQ) spoke on a planned conference call this evening that was moved to 6:30 PM EST rather than the 7:30 PM EST planned time.  They probably had a major steak dinner and 12 cases of...
This was Dendreon’s (DNDN-NASDAQ) big day, and may be what will end up as the largest battleground stock so far in 2007.  This situation for Dendreon was hardly covered at all until the end of...
Dendreon (DNDN-NASDAQ) has only 1 trading day left before its FDA panel meeting over the potential backing of its Provenge tomorrow.  The FDA issued some critical postings last night ahead of its...
Dendreon(DNDN-NASDAQ) is going to be one of "THE TOP ISSUES" this week.  The company will have and FDA review panel on Thursday, and you should just expect that if you are an active trader or if you...
I have received comments on Dendreon (DNDN-NASDAQ) for this week that are both positive and negative on how well its Sipuleucel-T (Provenge) is thought of ahead of the FDA panel review this week. ...
Dendreon (DNDN-NASDAQ) started making a mystery move at the end of the day, but you have to look at its calendar to see why it moved.  It appears that the company has an FDA ADVISORY COMMITTEE...
Did you ever think the FDA or other industry-government regulatory and advisory boards were free from a conflict of interest?  If so, guess again.  Today the FDA is issuing some new guidelines that...
(AAPL) Apple & Cisco settled their iPhone trademark issue.(ADI) Analog Devices traded up 4% after beating estimates and signaling strengthening orders.(AMR) American Airlines raises its NYC-based...
Pharmacyclics, Inc. (PCYC-NASDAQ) is trading down over 40% pre-market after receiving a ‘refuse to file’ letter from the FDA for its new drug application for Xcytrin® Injection for the treatment...
(AAI) AirTran -$0.04 EPS vs -$0.04e.(AMGN) Amgen traded down 2% after light earnings.(AOD) Alpine Total Dynamic Dividend Fund sold 176 million shares at $20.00, raising $3.5 Billion for the...
Amgen (AMGN-NASDAQ) posted EPS of $0.90, but $0.71 on GAAP EPS.  Revenues were $3.73 Billion versus $3.7 Billion estimates.  Revenues are projected for $15.4 to $16 Billion for 2007 and adjusted...
(ALDN) Aladdin Knowledge $0.28 EPS before items versus $0.27 estimate; 2007 guidance looks a tad softon EPS but in-line on revenues.(AOS) A.O.Smith $0.62 EPS vs $0.50e; may have gains in number; sees...
Osiris Therapeutics (OSIR) was notified that its PROCHYMAL received FDA ‘Fast Track’designation, expediting thedevelopment of the stem cell treatment for Crohn’s Disease that fails to respond...
Do you want to get a shot at making your own 2007 forecats,predictions, and a even get a shot at making your own suggestions orsharing ideas?  The shot is yours if you want it.  If Time is going...
Do you want to get a shot at making your own 2007 forecats, predictions, and a even get a shot at making your own suggestions or sharing ideas?  The shot is yours if you want it.  If Time is going...