U.S. Food and Drug Administration
U.S. Food and Drug Administration Articles
We have compiled an updated lengthy 2009 American Society of Clinical Oncology, or ASCO, document showing many company cancer data presentations slated to start this weekend. This is broken down...
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We have run a watch list of companies under their own strategic review, and the number of biotech (or grouped with biotech) stocks under this description is just staggering. We published a full...
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General Mills, Inc. (NYSE: GIS) maybe facing the same types of battles many supplement and diet product companies have seen with the FDA over advertising claims. The good news is that this is not...
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Cannabis Science, Inc. (OTCBB: GFON), or Gulf Onshore, Inc. (GFON), is yet another public stock company which is going after the field of legalized medical marijuana. Just last week the company...
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Dendreon Corporation (NASDAQ: DNDN) has announced that its pivotal Phase 3 IMPACT study of PROVENGE in men with advanced prostate cancer data. While the data is incomplete, Dendreon said that the...
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Acorda Therapeutics, Inc. (NASDAQ: ACOR) is taking it right on the chin this morning. The company announced that it has received a “refuse to file letter” from the FDA regarding its New Drug...
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Pfizer Inc. (NYSE: PFE) is stopping its Phase III clinical trial of Sutent early. This is generally a scare over adverse events, but not in this case. Sutent apparently has shown such a...
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Dynavax Technologies Corp. (NASDAQ: DVAX) is the latest biotech implosion as shares are down some 75% today. The company gave an update on an FDA clinical hold on its investigational vaccine...
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Gilead Sciences Inc. (NASDAQ: GILD) is trading down this morning. Goldman Sachs maintained its buy rating on the stock, but took down its price target to $58 from $59. This report is after a...
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A usually quiet Cardica, Inc. (NASDAQ: CRDC) is seeing a huge move in its stock today on strong upside volume. The company has won FDA marketing approval to sell its PAS-Port Proximal Anastomosis...
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Geron Corporation (NASDAQ: GERN) announced today that the company received a verbal notice from the FDA that Geron’s Investigational New Drug (IND) submission for GRNOPC1, its cell therapy for...
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Adherex Technologies Inc. (AMEX: ADH) has announced that it has received an orphan drug designation for its ADH-1 from the FDA for the use of ADH-1 in conjunction with melphalan for the treatment of...
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CNBC’s Mike Huckman just announced what is going to be a disappointment for Dendreon (NASDAQ: DNDN) holders, and that may be an understatement. The House Committee will not be forcing any action...
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Medtronic, Inc. (NYSE: MDT) has just announced that it has received formal approval from the FDA to market its Endeavor Zotarolimus-Eluting Coronary Stent System for the treatment of coronary artery...
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Medarex, Inc. (Nasdaq: MEDX) this morning has announced the allowance of two separate investigational new drug applications filed with the FDA for MDX-1342: one for the treatment of chronic...
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