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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 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 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 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
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 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 12, 2008 Brian Lawler	The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers?
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 July 10, 2008 Brian Orelli	The Death of the Approvable Letter The name's changing, but for investors, little else will.
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 January 24, 2007 Brian Lawler	Neurocrine in the Green 2006 wasn't kind to the drug developer, but whatever happens with indiplon, Neurocrine's management deserves kudos for keeping investors well informed on the status of the drug and where the company stands as far as timelines go.
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 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 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool May 2, 2007 Brian Lawler	Progenics' Intriguing Study Results The development-stage drugmaker released clinical trial results for one of its compounds. Investors, take note.
The Motley Fool April 13, 2011 Brian Orelli	Drug Duo Escapes Advisory Panel Unharmed Pfizer and Novartis are on their way to expanding their cancer drug indications.
The Motley Fool December 15, 2006 Brian Lawler	Reformatting Encysive Yet another delay from the FDA leaves investors hanging.
The Motley Fool January 16, 2008 Brian Lawler	Better Safe Than Sorry at Theravance Pharmaceutical company Theravance is raising cash in advance of an FDA hearing. Investors, take note.
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 June 12, 2007 Brian Lawler	Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg.
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 February 3, 2010 Brian Orelli	Pfizer's Hedge Pays Off FDA wants more data from Pfizer's partner, Protalix on their treatment for Gaucher disease.
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 July 18, 2006 Brian Lawler	Neurocrine's Tale of Woe After a couple of tough months, Neurocrine released its second-quarter results. This may be a great stock to own -- if you have the stomach to tolerate the risk.
The Motley Fool August 1, 2007 Brian Lawler	Elan Gets a Vote of Confidence Elan receives some good news from an FDA advisory panel in the form of a recommendation to expand the use of Tysabri to treat Crohn's disease.
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 September 7, 2007 Brian Orelli	Merck Says No to This Protein An FDA advisory panel recommends unanimous approval of a new HIV drug from Merck. The new class of HIV medications fight the virus by blocking one key protein from entering cells.
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 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 December 3, 2007 Brian Orelli	Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol.
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 June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
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 May 5, 2008 Brian Orelli	A Short Wait for Discovery Labs? The company gets a third letter about Surfaxin, but should be able to satisfy the FDA soon.
The Motley Fool July 13, 2004 Charly Travers	With Pfizer Drug, HIV Retreats Pfizer's newest HIV treatment shows promise in a demanding market.
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 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 December 14, 2007 Brian Lawler	FDA Knocks Neurocrine a Knuckle Sandwich The FDA clobbers drugmaker Neurocrine with another delay.
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 28, 2010 Brian Orelli	Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson.
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 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 April 11, 2011 Brian Orelli	A Double Dose of Trouble for Big Pharma? Pfizer's Sutent and Novartis's Afinitor head in front of an FDA advisory panel.
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.
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 February 6, 2008 Brian Lawler	Neurocrine on the Upswing? Neurocrine Bioscience releases year-end numbers, and updates investors on the status of its top drugs.
The Motley Fool February 28, 2007 Brian Lawler	Discovery Prepares for Its Fate Discovery Labs announces its quarterly financial results as it prepares for another meeting with the FDA. Investors, take note.
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 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 November 7, 2007 Brian Orelli	Momenta Stopped Momenta and Novartis receive a not-approvable letter for their new drug application on their generic version of Lovenox, due to worries that it might cause an immune reaction. Investors, take note.