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The Motley Fool April 6, 2011 Brian Orelli	Killing Bacteria With the Help of a Friend Optimer Pharmaceuticals has signed up Cubist Pharmaceuticals as a marketing partner for at least the next two years.
The Motley Fool May 31, 2011 Brian Orelli	Down! Up! Which Way Will Optimer Go Next? Long-term prospects look good.
The Motley Fool April 4, 2011 Brian Orelli	Anti-Infective, Very Effective The FDA seems to like Optimer's new antibiotic.
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.
The Motley Fool December 31, 2007 Brian Lawler	Lower Expectations for Theravance The FDA decides to debate Theravance's lead drug, Telavancin, leading to a drop in share price.
The Motley Fool December 11, 2009 Brian Orelli	Gilead Gets the Experts on Its Side An advisory committee says yes after the FDA said no.
The Motley Fool April 1, 2011 Travis Hoium	Optimer Pharmaceuticals Shares Popped: What You Need to Know Shares of Optimer Pharmaceuticals jumped 12% today after positive news from the FDA was released.
The Motley Fool February 4, 2009 Brian Orelli	Not If, but When, for Lilly At least Lilly now knows that it's just a matter of time until the anti-clotting agent wins FDA approval.
The Motley Fool June 16, 2011 Brian Orelli	No Poke in the Eye Here What's the biggest sign that the Food and Drug Administration is all set to approve Regeneron Pharmaceuticals' Eylea? The briefing documents for the advisory committee contained a proposed version of the label.
The Motley Fool November 30, 2009 Brian Orelli	The FDA Moves the Goalposts The FDA sends a complete response letter to Theravance about its antibiotic Vibativ, which it's trying to get approved for treating patients with nosocomial pneumonia.
The Motley Fool May 29, 2009 Brian Orelli	Delayed, Reason Unknown As long as Bayer and Johnson & Johnson can answer the FDA's questions relatively quickly, it shouldn't affect the companies too much.
The Motley Fool November 28, 2008 Brian Orelli	The FDA's Killing Bug Killers Unfortunately for Johnson & Johnson and Swiss drugmaker Basilea Pharmaceutica, the FDA appears a little reluctant to take some of the data for the drugmakers' antibiotic ceftobiprole at face value.
The Motley Fool March 25, 2009 Brian Orelli	Wyeth: Now Approved to Kill More Bugs! Wyeth's antibiotic gets approved for another indication.
The Motley Fool May 29, 2009 Brian Orelli	The Clouds Are Parting The Food and Drug Administration has scheduled an advisory committee meeting for Aug. 4 to get input on whether the agency should approve generic versions of ViroPharma's antibiotic, Vancocin.
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 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 December 31, 2009 Brian Orelli	The FDA (Still) Hates Antibiotic Makers Johnson & Johnson and Basilea are the agency's latest victims.
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 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 November 10, 2009 Brian Orelli	3 Companies Looking for Gratitude Early These three small drug companies all have PDUFA dates in the next week: Cadence Pharmaceuticals... NeurogesX... Genzyme...
The Motley Fool December 19, 2008 Brian Orelli	Eli Lilly's Good News Misses the Mark EU approval of its blood thinner is nice, but U.S. approval is what will really matter.
The Motley Fool July 13, 2010 Brian Orelli	A Triple Delight: 3 Stocks All Up More Than 10% What's good for the obese goose is good for the gander when it comes to new drug treatments for losing weight.
The Motley Fool August 27, 2008 Brian Orelli	Another FDA Setback for Johnson & Johnson The company has to wait for an approval of its extended-release schizophrenia drug. Investors, take note.
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 June 20, 2011 Brian Orelli	See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely.
The Motley Fool December 30, 2008 Brian Orelli	The FDA Needs a Bake Sale Money seems to be at the root of the problem with the FDA right now. It's pretty clear that fees, even though they're up to over $1 million per marketing application, aren't enough to get things done in a timely manner.
The Motley Fool September 4, 2008 Brian Lawler	Sitting Tight in September This month, several drugmakers will hear about compounds awaiting approval, so we can expect some volatility in their share prices. Read on to see who's awaiting FDA news.
The Motley Fool November 4, 2008 Brian Orelli	Does the Supreme Court Control Your Investment? The Supreme Court is about to make a decision that could affect drug company investors.
The Motley Fool December 9, 2008 Brian Orelli	Presents or Coal From the FDA? Let's take a look at a few companies expecting FDA decisions this month and see whether they're more likely to get a present or a lump of coal in their marketing-application stockings.
The Motley Fool July 16, 2009 Brian Orelli	Keep Your Chin Up, J&J An FDA advisory committee smacked down its drug candidate.
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 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 November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
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 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 February 28, 2008 Brian Lawler	FDA's Mixed Signals for Theravance The FDA gives Theravance frustrating double messages about a lead drug.
The Motley Fool June 25, 2010 Brian Orelli	Mark Your Calendars: Obesity Drugs Take Center Stage Orexigen Therapeutics has been given an FDA advisory committee meeting date, completing the dates for the trio of obesity drugs up for review.
The Motley Fool March 28, 2011 Brian Orelli	Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news.
The Motley Fool April 13, 2009 Brian Orelli	Will These Drugs Get Past the FDA? Hopefully April won't bring showers of tears to these drugmakers: Eli Lilly... AstraZeneca... Bristol-Myers Squibb... Novo Nordisk... Johnson & Johnson...
The Motley Fool July 30, 2010 Brian Orelli	A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs.
The Motley Fool July 11, 2008 Brian Orelli	Pfizer Looking at a Level Playing Field An advisory panel says that epilepsy drugs don't need a black-box warning, news that is positive for drug companies -- that is, those other than Pfizer.
The Motley Fool September 10, 2008 Brian Lawler	A Pfizer Drug With a Cloudy Future The company offers another drug with mixed odds to the FDA.
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 19, 2007 Brian Lawler	Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. Investors, take note.
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 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 March 13, 2009 Brian Orelli	Will These Drugs Get Past the FDA? Let's take a look at which pharma companies are hoping to score with the FDA this month.
The Motley Fool August 14, 2008 Brian Lawler	A Potentially Painless PDUFA Date King Pharmaceuticals and Pain Therapeutics get an appointment with the FDA.
The Motley Fool May 29, 2008 Brian Lawler	Ligand Loses, for Now The FDA sends Ligand Pharmaceutical this message: approval unlikely, try again later.