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The Motley Fool February 28, 2007 Brian Lawler	Time to Buy Shares of Adolor? Drug developer Adolor announces its fourth-quarter financial results as investors await pivotal clinical trial results.
The Motley Fool April 11, 2007 Brian Lawler	Adolor: Down and Out? The drug developer announces dour clinical trial results. Shares of Adolor crashed nearly 60% on the news.
The Motley Fool September 14, 2007 Brian Lawler	FDA Keeps Adolor Waiting Adolor and partner GlaxoSmithKline continue playing the FDA waiting game, as the agency has still not decided whether to allow clinical trials of Adolor's top drug to continue.
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 August 29, 2007 Brian Lawler	Adolor Stays in the Ring Adolor takes another run at getting FDA approval for its lead drug. Shares of the biotech firm are up on news the FDA had accepted for review additional information about its ileus medication, Entereg.
The Motley Fool March 15, 2007 Brian Lawler	Adolor's New Plan Adolor updates investors on its plans for its lead drug program.
The Motley Fool September 5, 2006 Brian Lawler	Adolor: Positive Results, Negative Reaction The market seems confused by good results from Adolor's latest clinical trial. Investors willing to take a gamble on Adolor at this price may be in for huge rewards if the company and Glaxo can convince the FDA of Entereg's viability.
The Motley Fool January 22, 2008 Brian Lawler	Adolor Under the FDA's Spotlight The FDA releases its documents on Adolor's lead drug, with surprising good news in advance of an advisory panel discussion. Investors, take note.
The Motley Fool January 24, 2008 Brian Lawler	Adolor Advisory Panel Aftermath An FDA advisory panel votes favorably on Adolor's lead drug.
The Motley Fool February 12, 2008 Brian Lawler	A Pre-Emptive Strike on the FDA Adolor will likely be waiting an extra three months for a decision on its lead drug Entereg.
The Motley Fool November 30, 2007 Brian Lawler	FDA Throws Adolor a Bone Pharmaceutical company Adolor gets an advisory panel hearing on its lead drug. Investors, take note.
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 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 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 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 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 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
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 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 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 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 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 May 30, 2008 Brian Orelli	No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil.
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 October 16, 2007 Brian Orelli	Pozen Hedges Its Bets As promised, Pozen and partner GlaxoSmithKline announce that the pair have submitted a response to their approvable letter for Trexima, and that they plan to do an additional just-in-case safety trial.
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 February 1, 2011 Brian Orelli	Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.
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 August 27, 2010 Brian Orelli	Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen.
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 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 August 3, 2007 Brian Orelli	Another Headache for Pozen Investors Drugmaker Pozen might have to run one more trial for the FDA for its migraine drug.
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
The Motley Fool December 23, 2004 W.D. Crotty	Adolor Drug Comes Up Short The biotech company announces trial results that, once again, do not meet primary end points.
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 December 3, 2007 Brian Orelli	Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol.
The Motley Fool April 10, 2008 Brian Lawler	Glaxo Angers the FDA GlaxoSmithKline announces that the FDA has sent it a warning letter regarding its failure to meet certain post-marketing requirements for Avandia.
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 April 4, 2007 Brian Lawler	Novartis Gets Nicked Novartis pulls one of its top-selling drugs from the market. Investors should come to expect drug delays or similar issues popping up from time to time when doing their analysis of large pharmas.
The Motley Fool October 3, 2007 Brian Lawler	FDA Says Nay to Endo Endo Pharmaceuticals announces that the FDA issued a "not approvable" letter in response to the company's attempt to expand the label for migraine treatment Frova.
The Motley Fool June 15, 2007 Brian Lawler	Neurocrine Moves Ahead Neurocrine resubmits a marketing application for its lead drug. 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 April 3, 2007 Brian Lawler	Dendreon's Positive Panel Surprise Shares of the drugmaker jump after a FDA advisory panel finds in favor of its lead cancer compound.
The Motley Fool March 10, 2010 Brian Orelli	Up 160% With Room to Run You've got to love biotech and InterMune.
The Motley Fool September 17, 2010 Luke Timmerman	Cell Therapeutics OK'd to Sell Shares to Stay Alive Is the company being straight with shareholders?
The Motley Fool August 23, 2010 Brian Orelli	No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week.
The Motley Fool December 15, 2006 Brian Lawler	Reformatting Encysive Yet another delay from the FDA leaves investors hanging.
The Motley Fool May 31, 2011 Brian Orelli	5 Biotechs With Upcoming Clinical Trial Results Investors willing to stay in these stocks a little while could see substantial gains well ahead of FDA approvals.
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 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.