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The Motley Fool August 18, 2011 Brian Orelli	A Poke in the Eye From the FDA FDA extends its review of Regeneron Pharmaceuticals' macular degeneration drug by three months.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool February 16, 2010 Brian Orelli	For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward.
The Motley Fool January 28, 2011 Brian Orelli	Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result.
The Motley Fool September 29, 2011 Brian Orelli	Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA.
The Motley Fool June 16, 2011 Brian Orelli	Are Two FDA Approvals in One Week a Positive Sign? Bristol-Myers Squibb received Food and Drug Administration approval for its kidney transplant drug Nulojix yesterday, marking the second approval this week from the FDA.
The Motley Fool January 17, 2007 Brian Lawler	Dendreon in the Fast Lane The FDA speeds up review of Dendreon's leading drug candidate. Investors, take note.
The Motley Fool December 6, 2010 Brian Orelli	3-Month Delay? No Problem! Investors shrug off HGS' Benlysta delay. The Food and Drug Administration's delaying its decision on whether to approve Human Genome Sciences and GlaxoSmithKline's Benlysta shouldn't come as much of a surprise.
The Motley Fool September 9, 2010 Brian Orelli	Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September.
The Motley Fool December 31, 2007 Brian Lawler	The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency.
The Motley Fool August 17, 2007 Brian Orelli	Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully.
The Motley Fool January 14, 2008 Brian Lawler	Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure.
The Motley Fool November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
The Motley Fool January 31, 2008 Brian Lawler	Prioritizing Millennium The FDA grants a speedy review for Millennium Pharmaceuticals's lead multiple myeloma drug.
The Motley Fool March 3, 2009 Brian Orelli	A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals.
The Motley Fool June 15, 2011 Brian Orelli	Investors Need a Peephole Into FDA Offices Cell Therapeutics is gung ho about its resubmission, but investors only get one side of the story.
The Motley Fool May 9, 2007 Brian Lawler	Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note.
The Motley Fool August 12, 2008 Brian Lawler	The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers?
The Motley Fool November 8, 2007 Charly Travers	BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent.
The Motley Fool December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool June 21, 2007 Brian Lawler	Pfizer Gets Held Up The FDA issues an approvable letter for its novel HIV compound. Investors, take note.
BusinessWeek June 12, 2006 Catherine Arnst	Going From The Lab To Limbo The FDA has been delaying decisions on applications, and drugmakers are fuming.
The Motley Fool December 31, 2011 Brian Orelli	3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012.
The Motley Fool November 29, 2010 Brian Orelli	There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain.
The Motley Fool February 25, 2011 Brian Orelli	When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections?
The Motley Fool May 18, 2009 Brian Orelli	Is There Life After 600% Returns? Just because a drug company gets a massive increase in the stock price after a positive clinical trial or an FDA approval, that doesn't mean all the growth is completely factored into the stock price.
The Motley Fool February 26, 2011 Brian Orelli	FDA Applications and a Look Ahead It isn't pretty.
The Motley Fool November 3, 2009 Brian Orelli	A Little Distracted, Are You, Merck? The FDA rejects its latest application.
The Motley Fool January 21, 2009 Brian Orelli	Pharma Foe Speaks Up for Investors Some good ideas for President Obama's new Food and Drug Administration chief that would benefit investors in drug companies.
The Motley Fool September 5, 2006 Brian Lawler	Neurocrine Wakes Up Indiplon The biotech company announces new drug delays. Investors, take note.
The Motley Fool November 14, 2007 Brian Lawler	Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years.
The Motley Fool June 26, 2008 Brian Orelli	The FDA's Latest Victim Merck fails to get its Gardasil vaccine approved to treat older women.
The Motley Fool May 13, 2011 Brian Orelli	FDA Advisory Panel Positive! Shares Punished. Despite the positive recommendation, investors aren't convinced BioMimetic's Augment will be approved.
The Motley Fool June 24, 2011 Brian Orelli	Come on, Pfizer, Not Even a Little Hint? Remoxy is rejected, but why?
The Motley Fool February 10, 2009 Brian Orelli	Roses and Candy From the FDA? Some drugmakers expect the FDA to bestow its kiss of approval this month. Read on to see who.
The Motley Fool March 13, 2008 Brian Lawler	Dendreon Rolls the Dice The pharmaceutical amends a phase 3 study on its lead prostate cancer drug.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
The Motley Fool August 21, 2008 Brian Orelli	Johnson & Johnson Gets Rejected The FDA rejects Johnson & Johnson's bid to expand the label of its antibiotic.
Pharmaceutical Executive January 1, 2006 Kenneth I. Kaitin	Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do.
The Motley Fool March 16, 2010 Brian Orelli	How to Lose $114 Million in One Day You've got to be a very trusting investor to buy shares in pharmaceutical company, MannKind.
The Motley Fool December 31, 2007 Brian Lawler	Does Leadership Count at the FDA? Let's take a look at how drug approval rates have fared under different FDA commissioners.
The Motley Fool June 18, 2010 Brian Orelli	Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday.
The Motley Fool June 1, 2007 Brian Lawler	Dendreon Gains. Why? Shares of the biopharma rise after it announces already expected news.
The Motley Fool April 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
The Motley Fool August 18, 2011 Brian Orelli	Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.
The Motley Fool September 19, 2008 Brian Lawler	FDA Tells Gilead to Take 1 More Step There's a small consolation prize for Gilead Sciences in this rejection from the FDA.
The Motley Fool October 14, 2011 Sean Williams	7 FDA Decisions You Can't Afford to Ignore in Q4 These stocks are bound to move as the FDA weighs in on their prospective drugs in Q4: Bristol-Myers... BioSante... Teva... Regeneron... Transcept... Incyte... Antares Pharma...
The Motley Fool June 18, 2009 Daniel Harrison	Is Dendreon Just a Dot-Com Story at This Price? The stock has had a really good year, but now it may be time to lock in the gains.
The Motley Fool March 3, 2009 Brian Orelli	Stop Worrying About Follow-On Biologics They're inevitable, but they won't hurt biotech as much as you might think.
The Motley Fool December 29, 2006 Brian Lawler	Third Time's the Charm for Encysive? It seems like every other week we hear about a new delay for Encysive's lead drug Thelin. With shares of Encysive down more than 20% yesterday, investors can only hope that the third time is the charm for Thelin's approval from the FDA.