U.S. Food and Drug Administration
U.S. Food and Drug Administration Articles
Shares of Momenta Pharma (MNTA) are off 46% to $7.27, a 52-week low. The company said said Tuesday the Food and Drug Administration denied approval for its blood clot drug enoxaparin sodium, being...
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Trimeris Inc. (NASDAQ:TRMS) is feeling a little after-hour pressure. Roche and Trimeris today provided an update on their combined efforts to offer a needle-free device which has been investigated...
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Cephalon Inc. (NASDAQ:CEPH) is a biotech that has been under a bit of a low ceiling after its recent blunder regarding FENTORA. As a reminder FENTORA is that cancer pain drug that the company...
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The Grocery Manufacturers Association is going to ask the government to strengthen regulation of food imports. The group, which includes Kraft (KFT) and Coca-Cola (KO) wants "beef up federal...
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Amgen Inc. (NASDAQ:AMGN) is seeing shares trade up another 2% pre-market after yesterday’s decision where an FDA panel rejected a proposal to set a specific target for red blood-cell levels in...
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Dendreon Corp. (NASDAQ:DNDN) will release earnings next Tuesday, August 7, after the close. The volatility in shares has dried up considerably as shares have only traded above $8.00 or below $7.00...
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CryoCor Inc. (CRYO-NASDAQ) is trading up almost 100% in early trading today. Last night the company announced that an FDA Advisory Panel had recommended backing the company’s pre-market approval...
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Shares of Dendreon (DNDN) are trading down some 7% pre-market after the company announced that it was going to offer $75 million in convertible senior subordinated notes that are due in 2014. The...
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Banc of America has noted that yesterday’s ‘positive data’ is actually not new and that the interim data will not be available until the second half of 2008. Mitchell Gold, MD/PhD/CEO of...
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Dendreon (DNDN-NASDAQ) is benefitting from something that become thought of as a low probability event: an FDA that buckled at least a little to peer pressure. It has received confirmation that...
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If you thought the day would never come that Dendreon (DNDN-NASDAQ) would see its volatility, its hyperactive volume, and its options premium compress to something back to almost normal, guess again:...
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Dendreon Corp. (DNDN-NASDAQ) was downgraded from an “Outperform” rating to a “Market Perform” rating. The brokerage sees uncertainties and risks going into an expected meeting FDA meeting...
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Dendreon (DNDN-NASDAQ) has only up to 4 full trading before that May 15 FDA review date. The funny thing here is that the options have actually become more expensive since reporting on this last...
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A.G.Edwards has initiated the recently volatile and controversial Dendreon (DNDN-NASDAQ) with a Hold/Speculative rating. The summary points are that it is starting the biotech as a Hold rated stock...
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Dendreon’s short interest actually grew again in April from 26.4 million shares in March to 33.9 million shares. The short interest was listed as 16.8 million shares in February. That is almost...
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