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The Motley Fool October 9, 2006 Brian Lawler	New Drug for New River An approvable letter from the FDA sends shares of New River Pharmaceuticals up.
The Motley Fool February 26, 2007 Brian Lawler	Shire's Busy Week Shire Pharmaceuticals announces year-end results, new regulatory approval, and another acquisition.
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 October 30, 2006 Brian Lawler	Building a Future Shire ADHD drugs are big for Shire now, but the long term isn't as clear. Investors, take note.
The Motley Fool July 27, 2007	Shire's Got Focus: Fool by Numbers Revenue and guidance are up at Shire, led by improved sales of their ADHD drugs.
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 15, 2006 Brian Lawler	Reformatting Encysive Yet another delay from the FDA leaves investors hanging.
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 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 November 9, 2006 Brian Lawler	Noven Might Be in a Purple Patch Investors in Noven shares might as well pay most of their attention to Shire, because as long as Daytrana does well, so too will Noven.
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 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 30, 2008 Brian Orelli	No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil.
The Motley Fool June 30, 2008 Brian Orelli	Johnson & Johnson Grows Up a Little Its Concerta for attention-deficit disorder is approved for use in adults.
The Motley Fool March 31, 2011 Brian Orelli	Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good.
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 May 2, 2007 Mike Havrilla	Consider Cortex New findings may give Cortex's ADHD drug the lift it needs. The news represents an excellent opportunity for speculative biotech investors
The Motley Fool December 28, 2010 Brian Orelli	Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson.
BusinessWeek October 24, 2005 Gene G. Marcial	Undivided Attention For An ADHD Battle Sales of Shire Pharmaceuticals' Adderall XR, the leading ADHD drug, are up.
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 August 20, 2007 Brian Lawler	Are These Perfect Pharma Acquisitions? Weighing recent drug-industry deals' odds of success: AstraZeneca and MedImmune... Shire and New River Pharmaceuticals... Gilead and Myogen...
The Motley Fool December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool January 25, 2007 Brian Lawler	Discovery Finds Its Way Even though Discovery Laboratories has been in control of its manufacturing plant for only one of the approvable letters, another failure to get approval of Surfaxin will probably be strike three for most investors.
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 26, 2007	Sales Up at Shire Pharmaceuticals: Fool by Numbers The drugmaker released fourth-quarter 2006 earnings: Income Statement Highlights... Margin Checkup... Balance Sheet Highlights... Cash Flow Highlights...
BusinessWeek August 22, 2005 Gene G. Marcial	New River May Have A "Blockbuster" For ADHD New River Pharmaceuticals has yet to make a dime - but investors love it.
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.
ifeminists May 24, 2006 Gerald K. McOscar	ADHD Is it child abuse per se for parents to allow doctors to prescribe mind altering drugs with potentially serious or fatal psychiatric side effects to their children, no matter how challenged...or challenging?
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 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 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 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 December 1, 2013	FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler.
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 5, 2005 W.D. Crotty	Cashing In on Noven's Drug Patch An FDA advisory panel recommends approval of Noven's patch for attention deficit hyperactivity. For now, investors might be put off by the company's lofty valuation of 55 times trailing earnings.
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 May 11, 2006 Brian Lawler	Encysive Evasive About Thelin The pharmaceutical stays tight-lipped about FDA approval of its new drug. Investors should keep an eye on Encysive's cash-burn rate in the coming months.
Chemistry World June 23, 2014 Phillip Broadwith	Shire fends off AbbVie takeover bid Shire is the latest pharmaceutical company to be targeted for a multi-billion dollar takeover deal from a firm looking to transfer its tax residence outside the US.
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 18, 2010 Brian Orelli	Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance.
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 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 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 October 5, 2011 Brian Orelli	1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response.
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 September 5, 2007 Brian Lawler	Not Your Typical Product Recall Shire and Noven will fix an annoying foible of their ADHD patch, Daytrana, making the back adhesive easier to unpeel.
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 3, 2010 Brian Orelli	Pfizer's Hedge Pays Off FDA wants more data from Pfizer's partner, Protalix on their treatment for Gaucher disease.