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The Motley Fool February 11, 2009 Brian Orelli	The FDA's Bipolar Decision Johnson & Johnson announces that the FDA has asked for more information before approving its application to market Risperdal Consta for frequently relapsing bipolar disorder.
The Motley Fool May 19, 2009 Brian Orelli	Flip-Flopping: Not Just for Politicians Anymore The FDA's change is good for companies.
The Motley Fool February 29, 2008 Brian Lawler	FDA Floors Eli Lilly Eli Lilly receives an especially harsh rebuke from the FDA about one of its top candidates when the agency refused to approve a long-lasting injection version of its multibillion-dollar Zyprexa for schizophrenia and bipolar disorder.
The Motley Fool August 24, 2007 Brian Orelli	Kids, Take Your Psychoactives J&J gains pediatric approval of its antipsychotic drug. Investors, take note.
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 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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
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 December 14, 2009 Brian Orelli	Finally Released From an Extended Review The FDA finally approves extended-release Zyprexa.
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 May 18, 2009 Brian Orelli	Is There Life After 600% Returns? Just because a drug company gets a massive increase in the stock price after a positive clinical trial or an FDA approval, that doesn't mean all the growth is completely factored into the stock price.
The Motley Fool January 8, 2009 Brian Orelli	FDA Toys With Lilly, and Investors, Again Eli Lilly will have to wait a little longer.
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 June 11, 2009 Brian Orelli	Kids, Take Your Antipsychotics! Drugs to combat mental illness might gain FDA approval for children.
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 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 March 10, 2010 Brian Orelli	Up 160% With Room to Run You've got to love biotech and InterMune.
The Motley Fool December 31, 2007 Brian Lawler	The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency.
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 June 18, 2010 Brian Orelli	Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday.
The Motley Fool December 9, 2008 Brian Orelli	FDA Dashes Amylin Investors' Hopes Shareholders are still waiting to hear how much longer it'll be before Amylin and Eli Lilly can submit the marketing application for the once-weekly version of diabetes drug Byetta.
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 December 31, 2011 Brian Orelli	3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012.
The Motley Fool January 14, 2009 Brian Orelli	FDA's Bipolar Decision on Schering's Drug Signs point to an approval for Schering-Plough's schizophrenia and bipolar drug Saphris, but there isn't one yet.
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 31, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.
BusinessWeek March 11, 2010 Margaret Cronin Fisk et al.	Did J&J Plan to Break Rules? Its aggressive marketing campaign for Risperdal has caused an explosion of litigation.
The Motley Fool November 26, 2010 Brian Orelli	Black Friday Biotech Bargains Drugmakers on sale.
The Motley Fool December 1, 2008 Brian Orelli	It's Wait Until Next Year for These Drugmakers Drugs from AstraZeneca and Eli Lilly face delays because of the FDA. Both plan to resubmit their applications for approval in the first half of next year, but the delays likely will have different effects on the companies.
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 September 30, 2008 Brian Lawler	No Approval for You ... Yet The FDA makes Eli Lilly wait for word on a lead drug.
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 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 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 July 1, 2008 Brian Orelli	As the FDA Generics Office Turns The FDA reluctantly gives Teva a 180-day exclusive period to sell generic Risperdal.
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 26, 2011 Brian Orelli	FDA Applications and a Look Ahead It isn't pretty.
The Motley Fool January 27, 2011 Brian Orelli	Amylin Timeline Shortened -- Maybe Revenue down 6% year over year. Prescriptions of the company's top-selling drug, Byetta, down 5.9% quarter over quarter. Amylin Pharmaceuticals' fourth quarter wasn't pretty.
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 October 2, 2007 Brian Orelli	Amylin's Bittersweet FDA News Diabetes drug moves ahead, but not as much as the company wanted. If the FDA rejection was due to safety issues, that wouldn't bode well for Amylin's plans to develop the active ingredient in SYMLIN as a weight-loss drug. Investors, take note.
The Motley Fool January 26, 2009 Brian Orelli	Which One of These Is Not Like the Other? Bristol-Myers and Eli Lilly run into some comparability issues.
The Motley Fool May 31, 2011 Brian Orelli	Pay Attention, Biotech Investors Competitors and partners can't be ignored.
The Motley Fool November 14, 2008 Brian Orelli	Gravy or Turkey From the FDA? Johnson & Johnson, Genzyme, and AstraZeneca should be made aware of their FDA fate over the next few weeks.
The Motley Fool March 5, 2008 Brian Orelli	FDA (Indirectly) Thwacks Amylin The FDA's draft guidance puts a cloud of uncertainty over the makers of diabetes drugs.
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 January 31, 2008 Brian Lawler	A Zettlement for Zyprexa? Eli Lilly may be close to resolving a government lawsuit over improper marketing.
The Motley Fool June 26, 2008 Brian Orelli	The FDA's Latest Victim Merck fails to get its Gardasil vaccine approved to treat older women.
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 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 November 5, 2010 Brian Orelli	Better Late Than Never for Cymbalta Eli Lilly gets an expanded approval for Cymbalta.