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The Motley Fool August 10, 2010 Brian Orelli	When the Disease Matters Most in Drug Approval Glaxo's and Valeant's Potiga will go before an FDA advisory committee tomorrow.
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 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 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 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 November 5, 2008 Brian Orelli	A Byetta Beating The FDA gives Amylin and Alkermes a smack down, but neither company is knocked out yet.
The Motley Fool June 16, 2011 Brian Orelli	Are Two FDA Approvals in One Week a Positive Sign? Bristol-Myers Squibb received Food and Drug Administration approval for its kidney transplant drug Nulojix yesterday, marking the second approval this week from the FDA.
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 October 17, 2007 Brian Orelli	FDA Warning Might Be a Buying Opportunity The 3%-4% drops in the stock prices of Amylin and Alkermes, Amylin's partner in the development of a sustained-release version of Byetta, could be a good buying opportunity for investors.
The Motley Fool June 14, 2011 Frank Vinluan	GSK Epilepsy Drug Approved by FDA GlaxoSmithKline and drug partner Valeant Pharmaceuticals have received U.S. Food and Drug Administration approval on a new epilepsy drug, but it must be classified as a controlled substance.
The Motley Fool May 31, 2011 Brian Orelli	Pay Attention, Biotech Investors Competitors and partners can't be ignored.
The Motley Fool April 17, 2008 Brian Orelli	Headache Over for Pozen and Glaxo? The duo's FDA headache regarding their migraine drug is over, but a new one is about to begin.
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 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 June 29, 2009 Brian Orelli	REMS: Not Just for Sleeping Anymore Risk Evaluation and Mitigation Strategies is saving drugmakers from going into a deep sleep while they wait for Food and Drug Administration approval of their drugs.
The Motley Fool June 23, 2008 Brian Lawler	Wait a Little Longer, Ligand The FDA delays its review of GlaxoSmithKline and partner Ligand Pharmaceutical's blood-disorder drug Promacta.
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 November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
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 May 29, 2008 Brian Lawler	Ligand Loses, for Now The FDA sends Ligand Pharmaceutical this message: approval unlikely, try again later.
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 August 18, 2010 Brian Orelli	More Pain Ahead for Eli Lilly? An advisory panel meeting tomorrow could further the company's slide.
The Motley Fool December 8, 2010 Brian Orelli	Up 100% With Room to Fly Orexigen gets a positive FDA panel nod.
The Motley Fool November 13, 2009 Brian Orelli	Questioning Pfizer's Integrity Pfizer's epilepsy drug Neurontin has had generic competition for a few years, but it's still plaguing the pharmaceutical giant.
The Motley Fool March 7, 2005 Brian Gorman	Glaxo in Hot Water Glaxo's problems with the FDA could have been avoided. Investors can only hope that the FDA is in a forgiving mood.
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 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 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 30, 2004 Alyce Lomax	A Monster Drug for Lilly? The drug giant files a new drug application (NDA) for its experimental new drug for diabetics.
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 29, 2010 Brian Orelli	There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain.
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 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.
Chemistry World July 31, 2007 Victoria Gill	FDA Advised: Avandia Should Stay on the Market The US Food and Drug Administration's (FDA's) Advisory Committee came to an almost unanimous decision yesterday for Avandia, GlaxoSmithKline's much-maligned diabetes treatment, to remain on the US market.
The Motley Fool February 19, 2010 Brian Orelli	Breathe Deep. It Might Not Be That Bad. The FDA strikes down asthma drugs, but will doctors buy in?
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 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 19, 2010 Brian Orelli	When the Status Quo Is a Big Win The lack of an FDA rejection will do just fine. Amgen and Johnson & Johnson seemed to get through the FDA advisory panel process without much problem yesterday.
The Motley Fool November 1, 2010 Brian Orelli	Stock Doubles! No Crying Here AVANIR Pharmaceuticals' investors didn't have any uncontrolled crying on Friday when the Food and Drug Administration approved Nuedexta, the company's treatment for pseudobulbar affect.
The Motley Fool November 16, 2009 Brian Orelli	Music to Health-Care Investors' Ears Are faster FDA review times coming?
The Motley Fool December 6, 2010 Brian Orelli	3-Month Delay? No Problem! Investors shrug off HGS' Benlysta delay. The Food and Drug Administration's delaying its decision on whether to approve Human Genome Sciences and GlaxoSmithKline's Benlysta shouldn't come as much of a surprise.
The Motley Fool November 21, 2008 Brian Orelli	The Comeback of the Century? AstraZeneca is trying to revive Iressa.
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 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.
Pharmaceutical Executive January 1, 2006 Kenneth I. Kaitin	Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do.
The Motley Fool February 26, 2010 Brian Orelli	A Risky Deal, but at Least It's Cheap Glaxo licenses a preclinical compound from Regulus.
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 17, 2007 Brian Orelli	FDA's Rigor May Boost Sales The FDA is updating labeling of certain blood-thinning drugs, indicating that patients may want to obtain a genetic test prior to taking the medication. This move may lead to increased testing, and hopefully increased prescriptions.
The Motley Fool January 15, 2010 Brian Orelli	Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all.