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The Motley Fool March 27, 2009 Brian Orelli	Dyax: A Cinderella Story Ends in a Fall FDA asks Dyax for more information.
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 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 May 26, 2009 Brian Orelli	Will the FDA Approve These Drugs? Plenty of Prescription Drug User Fee Act dates are right around the corner. Read on to see which pharma companies may be affected.
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 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 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 July 29, 2010 Brian Orelli	This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either.
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 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
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 31, 2009 Brian Orelli	A Good Start for a Potential Blockbuster Novartis' FDA approval for Afinitor is nice, but it needs another indication to be a blockbuster.
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 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 June 2, 2010 Brian Orelli	Little Surprise. Big Stock Move. Investors like Amgen's early approval;shares are up 9% today, well ahead of the overall market.
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 July 8, 2008 Brian Lawler	Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards.
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 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 April 28, 2009 Brian Orelli	Headline? Bad! Unexpected? No! For a company that only has one drug on the market, stopping a failing phase 3 clinical trial that's designed to expand the market of that drug is usually a major blow. But Onyx Pharmaceuticals was able to shrug it off.
The Motley Fool June 4, 2010 Brian Orelli	This Cancer Drug's on a Roll Novartis' Afinitor scores another win.
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 December 31, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.
The Motley Fool November 26, 2010 Brian Orelli	Black Friday Biotech Bargains Drugmakers on sale.
The Motley Fool April 15, 2011 Brian Orelli	Fewer Needle Pricks for the Europeans Amylin's once-weekly diabetes drug Bydureon gets a positive recommendation in Europe.
The Motley Fool March 30, 2010 Brian Orelli	Invest in This Space at Your Own Risk Lung cancer is a tough foe for drugmakers.
The Motley Fool January 26, 2010 Brian Orelli	Is Victoza's Victory in Vain? Novo Nordisk finally gets the FDA to sign off on its once-daily diabetes drug.
The Motley Fool February 20, 2009 Brian Orelli	The Skinny on Diabetes Drugs The goal of diabetes drugs is to get the patient's blood glucose levels under control, but one class of drugs, called GLP1 agonists, have a nice side effect: weight loss. Which pharma companies can benefit?
The Motley Fool October 19, 2010 Brian Orelli	Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency.
The Motley Fool October 11, 2010 Brian Orelli	FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that.
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 February 22, 2010 Brian Orelli	Warning: Avandia Could Cause Drool Among Trial Lawyers An unintended side effect of Glaxo's Avandia might be excessive salivation among trial lawyers. A 342-page report by the Senate Finance Committee is painting the diabetes drug in a not-so-great light.
The Motley Fool April 15, 2011 Luke Timmerman	Amylin, Alkermes Shares Jump as EU Regulators Recommend Diabetes Drug Will this drug be approved in Europe?
The Motley Fool February 1, 2011 Brian Orelli	Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.
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 May 27, 2010 Brian Orelli	This Rabid Agency Could Permanently Damage Your Portfolio The FDA has gotten a little out of control. The wonkiness of the FDA's actions makes it hard for investors to figure out what the agency will do.
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 November 29, 2011 Brian Orelli	Winners and Losers of Roche's Avastin Woes What the FDA giveth, the FDA can taketh away.
The Motley Fool February 27, 2009 Brian Orelli	Get a Life, Congress! A Congressional investigation into whether the FDA was right to pull a doctor off of the advisory panel for Eli Lilly's blood thinner prasugrel illustrates why Congress needs to keep its nose out of scientific discussions.
Chemistry World July 16, 2010 Matt Wilkinson	Bittersweet victory for GSK's Avandia GlaxoSmithKline has received a muted 'thumbs up' from a US regulatory advisory panel for its much-maligned Type 2 diabetes drug Avandia (rosiglitazone), making it likely the US Food and Drug Administration will allow the UK-based pharma giant to continue selling the drug in the US.
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 April 28, 2011 Brian Orelli	Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval.
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 July 9, 2010 Brian Orelli	2 Days, 1 Blockbuster, Fate Unknown GlaxoSmithKline heads before a marathon two-day Food and Drug Administration advisory panel review of its diabetes drug Avandia.
The Motley Fool October 8, 2010 Luke Timmerman	Onyx Delays Cancer Drug Application As FDA Asks for More Data Shares fell about 7% in after-hours trading Thursday evening.
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 October 20, 2010 Brian Orelli	There Are No Safe Biotech Investments Amylin Pharmaceuticals and its partners, Eli Lilly and Alkermes, announced yesterday evening that the Food and Drug Administration had asked for more data before approving its once-weekly diabetes drug Bydureon.
The Motley Fool June 28, 2007 Brian Orelli	Onyx's Hard at Work Onyx's future depends on getting Nexevar approved for new indications. The liver cancer expansion is a nice start, and it should bring Onyx into the black. Investors, take note.
The Motley Fool December 27, 2010 Brian Orelli	FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered.
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.