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The Motley Fool December 19, 2007 Brian Orelli	New Beta Blocker on the Crowded Street Forest and Mylan receive FDA approval for Bystolic. Investors, take note.
The Motley Fool October 30, 2007 Billy Fisher	Is Forest Labs' Nebivolol Ready for Prime Time? Shareholders of the pharmaceutical company have been looking for a way to boost their floundering stock. The FDA's likely approval of hypertension drug Nebivolol may be the answer.
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 May 30, 2008 Brian Orelli	No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil.
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 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 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 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 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 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 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 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 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 April 16, 2008 Brian Orelli	Forest Labs' Race Against the Clock Investors don't seem to like Forest Labs' ambitious plans for research and development.
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 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.
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 December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
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 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 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 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 February 11, 2011 Brian Orelli	Biotech Optimists Throw In the Towel As the chance of survival improves, the stock falls. Wait, what?
The Motley Fool January 12, 2006 Stephen D. Simpson	Forest Keeps Reloading An agreement with Mylan Labs gives Forest access to a drug that could be launched in 2006. Investors, take note.
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 April 26, 2011 Brian Orelli	We Hate Your Drug. And That's a Good Thing. This one's a pain for the clinical trial participants.
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 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 December 9, 2008 Brian Orelli	The FDA Can't See the Forest or the Trees Forest Laboratories and Cypress Bioscience are still waiting for FDA approval, but now they've got more data to prove their point.
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 March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
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 August 9, 2010 Brian Orelli	Dendreon's in Trouble Provided you call a slap on the wrist from the FDA "trouble."
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 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 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 November 12, 2009 Brian Orelli	The Life-and-Death Situation That Isn't Branded-drug makers aren't playing fair because they refuse to sell samples to generic drug makers.
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 May 14, 2007 Brian Lawler	Dendreon Tries to Pick Up the Pieces Dendreon lays out its preliminary plans following a negative FDA regulatory decision. Investors shouldn't necessarily take the smashed-down share price as indicative of a possible biotech value play.
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 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.
The Motley Fool June 3, 2011 Brian Orelli	FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully.
The Motley Fool October 16, 2006 Brian Lawler	The Coming Generic Drug Boom Generic drugmakers are poised to profit from several key factors. Investors, take note.
The Motley Fool February 22, 2011 Ryan McBride	Forest Labs Snaps Up Clinical Data This deal is the latest proof that drug developers with FDA-approved treatments remain hot buyout targets in a pharma industry that is starved for new products to replace brand-name drugs.
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 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
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 December 14, 2007 Brian Lawler	FDA Knocks Neurocrine a Knuckle Sandwich The FDA clobbers drugmaker Neurocrine with another delay.
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 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.