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The Motley Fool April 17, 2007 Brian Lawler	Neurochem Must Wait The FDA delays a regulatory decision on Neurochem's lead compound. Investors, take note.
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 June 12, 2007 Brian Lawler	Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg.
The Motley Fool July 18, 2007 Brian Lawler	More Misery for Neurochem It's hard to find another drug developer that has mishandled its correspondence with investors about its drug candidates as badly as Neurochem has over the past year.
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.
The Motley Fool May 14, 2007 Mike Havrilla	Investors Tire of Inspire Pharmaceuticals Shares are down about 10% recently, despite approval for AzaSite.
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 June 21, 2007 Brian Lawler	Pfizer Gets Held Up The FDA issues an approvable letter for its novel HIV compound. Investors, take note.
The Motley Fool June 15, 2007 Brian Lawler	Encysive's Date With Destiny Approaches A decision on the specialty drugmaker's lead drug is imminent. Betting against the FDA is generally not a good idea for investors. Here are statements from Encysive's past press releases about Thelin
The Motley Fool April 23, 2007 Brian Lawler	Neurochem Sets Low Expectations The specialty drug developer announces an update on plans to release results from a clinical study. Investors, take note.
The Motley Fool December 15, 2006 Brian Lawler	Reformatting Encysive Yet another delay from the FDA leaves investors hanging.
The Motley Fool February 27, 2007 Brian Lawler	FDA Keeps Novartis Waiting The pharmaceutical experiences a regulatory setback in the U.S. for one of its top drug candidates. Investors, take note.
The Motley Fool September 24, 2007 Brian Lawler	Encysive Hears the Voice of Reason To please the FDA, Encysive Pharmaceuticals announces it is planning an additional phase 3 trial to try and bring its lead drug, Thelin, to market in the United States.
The Motley Fool November 8, 2006 Brian Lawler	Stumbling Block for Adolor Another approvable letter from the FDA means investors may have to be patient.
The Motley Fool December 10, 2007 Brian Lawler	Neurochem's Sure Bet at Failure Investors should add another regulatory date to their biotech calendars, this one regarding Neurochem's lead drug, KIACTA.
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 December 28, 2010 Brian Orelli	Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson.
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 January 14, 2005 W.D. Crotty	An FDA OK That Hurts EPIX Pharmaceuticals gets a qualified "yes" from the FDA, sending its stock tumbling.
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 June 15, 2007 Brian Lawler	Neurocrine Moves Ahead Neurocrine resubmits a marketing application for its lead drug. 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 January 16, 2008 Brian Orelli	Headache Almost Over for Pozen The drug is safe; hopefully that's all the FDA wanted to know.
The Motley Fool September 6, 2007 Brian Lawler	Encysive, Please Stop Its failure to acquiesce to the FDA's request means the competition is going forward as this drugmaker's product stays stagnant. Investors, take note.
The Motley Fool March 30, 2010 Brian Orelli	FDA Lags, Investors Flee Cephalon gets no love from the FDA. The agency failed to expand Cephalon's Nuvigil for the treatment of jet lag.
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 October 8, 2007 Brian Orelli	Pozen Submits Safety Data Will Pozen's response to its second approvable letter be enough? Investors may want to take this with a grain of salt.
The Motley Fool August 27, 2010 Brian Orelli	Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen.
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 August 3, 2009 Brian Orelli	The Roller-Coaster Stock That Keeps on Giving Savient's gout treatment isn't approved just yet.
The Motley Fool December 27, 2011 Brian Orelli	2011 No Dreamboat for MannKind An FDA rejection and a long wait is a bad combination.
The Motley Fool April 2, 2007 Brian Lawler	FDA Keeps Cephalon Waiting The FDA issues Cephalon an approvable letter for one of its drugs. 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 October 30, 2007 Billy Fisher	Is Forest Labs' Nebivolol Ready for Prime Time? Shareholders of the pharmaceutical company have been looking for a way to boost their floundering stock. The FDA's likely approval of hypertension drug Nebivolol may be the answer.
The Motley Fool June 18, 2007 Brian Lawler	The Third Time Isn't the Charm for Encysive The approvable letter for the pulmonary arterial hypertension treatment marks the third time Thelin has failed to get full approval from the FDA. Investors, take note.
The Motley Fool December 14, 2007 Brian Lawler	FDA Knocks Neurocrine a Knuckle Sandwich The FDA clobbers drugmaker Neurocrine with another delay.
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 October 8, 2010 Luke Timmerman	Onyx Delays Cancer Drug Application As FDA Asks for More Data Shares fell about 7% in after-hours trading Thursday evening.
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 January 20, 2011 Brian Orelli	This Stock Is No Dreamboat The FDA is not kind to MannKind.
The Motley Fool December 11, 2006 Brian Lawler	Another Go for Encysive Drug Trials Sometimes shares of small specialty-pharma stocks rise and fall much more than warranted on every piece of news, and this appears to have happened to Encysive Pharmaceuticals.
The Motley Fool April 29, 2008 Brian Orelli	Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month.
The Motley Fool March 8, 2010 Brian Orelli	Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting.
The Motley Fool February 1, 2011 Brian Orelli	Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.
The Motley Fool July 29, 2010 Brian Orelli	This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either.
The Motley Fool June 3, 2011 Brian Orelli	FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully.
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 August 24, 2009 Brian Orelli	J&J Would Rather Not Say Drug delayed, reason unknown. Should shareholders be worried? It's hard to tell.
The Motley Fool December 24, 2009 Brian Orelli	Another Reason to Worry About Pfizer The FDA fails to approve Lyrica for treating anxiety.
The Motley Fool October 11, 2010 Brian Orelli	FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that.