Fda News & Views

Updated 7 months ago   More news & views
What Would You Do With the FDA? Pt1 External-link
Featuring Donald Berry, Joe Kiani, Steve Nissen, Andrew von Eschenbach
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Source: Forbes
Dec 07, 2013 - 3:07 PM
Browse Related Topics:   Andrew Joe Kiani Steve Nissen
Neuralstem Phase I Results Encourage Market, Stimulate Buying External-link
By Brian L. Wilson:Although it seems that investors have lost their appetite for many stem cell investments at this stage of the broader rally in the stock market, there are exceptions worth pointing out. Neuralstem (NASDAQ: CUR), for instance, has been in a strong uptrend since, on April 17th, the company finally r...
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Source: Seeking Alpha
May 22, 2013 - 12:33 AM
Browse Related Topics:   Neuralstem Of Complete... Brian L. Wi...
Don't Lose Sleep Over Merck's Insomnia Drug External-link
An FDA panel will likely recommend approval of suvorexant despite concerns.
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Source: Wall Street Journal
May 22, 2013 - 12:29 AM
Hologic gets FDA OK for 3-D mammo technology External-link
Hologic Inc. (Nasdaq: HOLX) on Tuesday received approval of its breast screening software. The Bedford, Mass. developer of diagnostics, medical imaging systems and surgical product said its new 2-D imaging software got the OK by the U.S. Food and Drug Administration. The approval means that C-View 2-D images may n...
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Source: Boston Business News -...
May 21, 2013 - 11:22 AM
Browse Related Topics:   Mass. U.S. Food A... Bedford Hologic
Biogen Idec seeking approval from the FDA for an injectable multiple sclerosis drug External-link
Biogen Idec Inc., which cemented its place as the dominant multiple sclerosis drug maker in March when it won US approval to sell an MS pill, said Tuesday it has applied to the Food and Drug Administration to market a third injectable MS drug.    
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Source: Boston Globe
May 21, 2013 - 10:08 AM
Browse Related Topics:   Food And Dr... Us Biogen Idec
Impax calls on former Teva, Watson execs to confront FDA issues External-link
Having failed so far to get its extended-release Parkinson's drug Rytary to market, Impax Laboratories ($IPXL) is turning to asking three big-name specialists what it should do.
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Source: FierceMarkets
May 21, 2013 - 8:52 AM
Browse Related Topics:   Teva Watson Impax Labor...
Synergy Is A Straightforward Opportunity: Trial Results At DDW Back Plecanatide External-link
ByPropThink: By Jake King It doesn't get much better than this, and Synergy Pharmaceuticals (SGYP) remains a favorite idea. The company's lead drug candidate, plecanatide, has demonstrated strong safety and efficacy results in a 951-patient clinical trial, there's a path to FDA approval, and the company is trading...
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Source: Seeking Alpha
May 21, 2013 - 6:41 AM
Browse Related Topics:   Synergy Pha... Irwd Ironwood Jake More    
Biogen Idec seeks FDA approval for new MS drug External-link
Weston-based Biogen Idec said today it has submitted a biologics license application to the U.S. Food and Drug Administration for approval of an injectable drug called Plegridy to treat relapsing forms of multiple sclerosis.The submission was based on the results from the first year of a two-year global Phase 3 ADVA...
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Source: Boston Herald
May 21, 2013 - 4:21 AM
Browse Related Topics:   U.S. Food A... Biogen Idec
2013 FDA Drug Approval Calendar External-link
BOSTON (TheStreet) -- Gilead Sciences and Amarin highlight the updated list of biotech and pharmaceutical companies with FDA drug approval decisions expected for the remainder of 2013. The next era of hepatitis C therapy could begin on Dec. 6, if FDA approves Gilead's sofosbuvir. Amarin is hoping FDA approves a...
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Source: The Street
May 21, 2013 - 4:00 AM
Browse Related Topics:   Boston Pharmacyclics Gilead Scie... Gilead More    
A Game-Changing Cancer Screen For Exact Sciences External-link
By Biotech Vet:Recently, Exact Sciences (EXAS) of Madison, WI, released the top line results from their pivotal Deep-C trial to nail down the performance characteristics of their proprietary stool DNA test. The release of the top-line results led to one of the strangest trading days you'll ever see with the news ini...
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Source: Seeking Alpha
May 21, 2013 - 3:57 AM
Browse Related Topics:   Madison Sqnm Exact Sciences Exas
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FDA Videos

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Today in History May 9


May 9, 2013 - 4:11 AM Highlights of this day in history: The FDA approves the first birth control pill; FCC ...
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FDA calls for cancer warning labels on tanning beds


May 7, 2013 - 5:29 PM The federal government wants stronger warnings on indoor tanning beds as more young peo...
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GM issues recall for car batteries that may cause fire


May 7, 2013 - 4:37 PM Stocks opened higher after some positive news on housing, General Motors is recalling o...
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FDA approves over-the-counter morning-after pill for teens


May 1, 2013 - 7:47 PM Girls as young as 15 will soon be able to walk into any drugstore and buy a controversi...
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FDA: Morning-after Pill to Move Over the Counter


May 1, 2013 - 3:00 AM The government is moving the morning-after pill over the counter but only those 15 and ...
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FDA: Morning-after Pill to Move Over the Counter


May 1, 2013 - 1:02 AM The government is moving the morning-after pill over the counter but only those 15 and ...
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Subaru recalling thousands of Forester wagons


Apr 30, 2013 - 7:11 PM Subaru is recalling newer models of its Forester wagon, the FDA is investigating whethe...
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Biotech's Next Big Thing: Aveo


Apr 25, 2013 - 1:36 PM TheStreet Sr. Columnist Adam Feuerstein says FDA reviews for cancer drugs from Aveo and...
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Futures Rise on Key Earnings


Apr 23, 2013 - 12:04 PM US stock futures are rising on strong earnings from DuPont and Coach, while Amarin gets...
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Legalized Marijuana Spreads Before FDA Approves


Apr 17, 2013 - 3:06 PM April 17 (Bloomberg) -- Bloomberg's Olivia Sterns explores the booming business of Mari...