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The Motley Fool June 24, 2009 Brian Orelli	This Just Makes Me Sick! GlaxoSmithKline's anti-nausea medication Rezonic's marketing approval was turned down by the Food and Drug Administration, reason unknown.
The Motley Fool November 3, 2009 Brian Orelli	A Little Distracted, Are You, Merck? The FDA rejects its latest application.
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 July 10, 2008 Brian Orelli	The Death of the Approvable Letter The name's changing, but for investors, little else will.
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 January 21, 2011 Brian Orelli	Mark Your Calendar, Drug Investors Vertex announces that the Food and Drug Administration has accepted its New Drug Application to market telaprevir.
The Motley Fool June 3, 2009 Brian Orelli	No More Triple-Digit Returns? If FDA decisions could be predicted easily, investors might not get to enjoy triple-digit returns, so perhaps we shouldn't be too upset about the tight-lipped nature of the FDA.
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 15, 2006 Brian Lawler	Reformatting Encysive Yet another delay from the FDA leaves investors hanging.
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 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 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 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 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 May 31, 2011 Brian Orelli	Pay Attention, Biotech Investors Competitors and partners can't be ignored.
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 November 29, 2010 Brian Orelli	There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain.
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 August 9, 2010 Brian Orelli	Dendreon's in Trouble Provided you call a slap on the wrist from the FDA "trouble."
The Motley Fool December 12, 2008 Brian Orelli	Amylin Gets Some FDA Love Amylin's once-weekly diabetes drug Byetta gets a green light from the FDA.
The Motley Fool January 21, 2009 Brian Orelli	Pharma Foe Speaks Up for Investors Some good ideas for President Obama's new Food and Drug Administration chief that would benefit investors in drug companies.
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 November 15, 2007 Charly Travers	John Edwards, Frozen Caveman Lawyer Presidential hopeful John Edwards' health-care plans could destroy drug research and development in this country by removing the patent protection on breakthrough drugs.
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 May 27, 2009 Brian Orelli	Meet the People Who'll Rule Your Investment Life If you're a drug company investor, that is. The new commissioner and principal deputy commissioner of the Food and Drug Administration introduced themselves and give investors a first look at how they plan to run the agency.
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 December 14, 2007 Brian Orelli	Panel Kills Merck's Hope of OTC Status An FDA advisory panel isn't convinced that Merck's cholesterol-lowering drug MEVACOR deserves OTC status.
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 January 31, 2007 Brian Lawler	FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer.
The Motley Fool September 16, 2008 Brian Lawler	Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site.
Pharmaceutical Executive November 1, 2008 Patrick Clinton	Over There Is it the FDA's responsibility to be in charge of inspections at foreign pharmaceutical plants?
The Motley Fool March 15, 2010 Brian Orelli	FDA Says "No Way!" Market Says "Yeah, Baby!" You can have it both ways. The Food and Drug Administration's response wasn't exactly what investors in Amylin Pharmaceuticals, Eli Lilly, and Alkermes were looking for, but they'll take it.
The Motley Fool September 15, 2010 Brian Orelli	Drug Approved. Now Let's Sell This Baby! With ink still wet on its FDA approval, Savient continues its plan to find a buyer.
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 June 23, 2006 Stephen D. Simpson	Neurocrine Biosciences: From Bad to Worse Pfizer's departure is a serious, though not fatal, blow to the biotech. While this story may yet have a happy ending, there's going to be a lot of nervous waiting between now and then. Investors, take note.
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 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 January 31, 2011 Brian Orelli	5 Drugmakers Headed Back to the Drawing Board Sometimes an FDA rejection is more of a to-do list.
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 November 27, 2009 Brian Orelli	A Mostly Meaningless FDA Approval After an accelerated approval, the positive effects of a full approval are minimal for Johnson & Johnson's drug, Intelence.
The Motley Fool December 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
The Motley Fool August 22, 2007 Brian Orelli	Regulating the Drug Pushers The FDA might get a little tougher on drug ads, following a report that they may not be watching advertisers claims closely enough, or warning patients about side effects strongly enough.
The Motley Fool June 26, 2009 Brian Orelli	Looking for a Sliver of the Me-Too Pie Another diabetes drug is close to hitting the market.
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 April 6, 2009 Brian Orelli	FDA to Search Engines: You Lose! FDA cracks down on pharma ads, but search engines are the real losers. The FDA wants the drugmakers to stop making claims in sponsored link advertisements.
The Motley Fool December 14, 2009 Brian Orelli	Finally Released From an Extended Review The FDA finally approves extended-release Zyprexa.
The Motley Fool November 13, 2007 Brian Orelli	Another Punch in the Nose for Pfizer The FDA clears ZYRTEC-D for over-the-counter sales; marketing of the medication will now switch hands from Pfizer to Johnson & Johnson. Investors, take note.
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 April 8, 2004 Charly Travers	Indevus' Big Score (Maybe) A small biotech company lands a potentially rich deal.