FDA

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5 Big FDA Decisions Expected in September

Pharmaceutical companies usually are involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, similar to that ...
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How Amgen Can Disrupt the Market for Cholesterol Drugs

Amgen Inc. (NASDAQ: AMGN), known as a leading biotech in its field, made waves in the market on Friday morning. This biotech giant has the potential to disrupt the market ...
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FDA Grants Expanded Use of Promacta for Novartis

Novartis AG (NYSE: NVS) is one of the few companies with good news on a major market sell-off. Unfortunately, it is not big enough news to be moving the shares. ...
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Will Sprout Pharmaceuticals Go Public?

Privately held start-up Sprout Pharmaceuticals Inc. received U.S. Food and Drug Administration (FDA) approval on Tuesday for its flibanserin pill with the trade name Addyi. The pill has become known ...
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Esperion Updates Phase 2 Study and Keeps Volatility Traders Interested

Esperion Therapeutics, Inc. (NASDAQ: ESPR) had a huge move in Monday’s trading session as the result of an analyst upgrade but it looks like this company has kept the rally ...
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Why the FDA Extended Review Date on Key Melanoma Drug Opdivo

Bristol-Myers Squibb Co. (NYSE: BMY) was recently featured by 24/7 Wall St. on the calendar of five key upcoming FDA events to watch in the bio-health sector. Now there is ...
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biotech

Can Aquinox Sustain Its Massive Rally?

Despite having a market cap of less than $50 million, Aquinox Pharmaceuticals Inc. (NASDAQ: AQXP) made waves in the market on Friday morning with shares up over 200%. The company ...
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5 Big FDA Decisions Expected in August

Pharmaceutical companies usually are involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, similar to that ...
Read Full Story »
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Will Biogen Win From Novartis MS Drug Safety Label Change?

There are times when a negative piece of news in the BioPharma sector can actually help rival companies. Biogen Inc. (NASDAQ: BIIB) is a stock that has been battered of ...
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Is This the End of Sunesis?

Sunesis Pharmaceuticals Inc. (NASDAQ: SNSS) probably wishes that this Friday never happened. The company was already a very speculative cancer drug biotech outfit, and now its status is moving down ...
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Is This the End for XOMA?

XOMA Corp. (NASDAQ: XOMA) stumbled in trading Wednesday morning, perhaps fell off a cliff might be more accurate. In only the first hour of trading alone, over 22 million shares ...
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What FDA Breakthrough Therapy Designation Means for Dyax

Dyax Corp. (NASDAQ: DYAX) announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted a key breakthrough therapy designation for the investigation of DX-2930 for hereditary angioedema ...
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5 Big Upcoming FDA Decisions Expected in July

Pharmaceutical companies usually are involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, similar to that ...
Read Full Story »
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Sarepta Takes Its Foot off the Gas

Considering that a Greek exit might be on the way, the broad markets have sold off a fair amount, and across the markets companies are losing out. Sarepta Therapeutics Inc. ...
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New Mega-Blockbuster Cholesterol Drug Class Faces Make-or-Break FDA Panels

This coming week is likely to be a serious one in the fight against cholesterol. This covers a new class of drugs in the PCSK9 classification, and FDA panels are ...
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