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The Motley Fool August 3, 2009 Brian Orelli	The Roller-Coaster Stock That Keeps on Giving Savient's gout treatment isn't approved just yet.
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, 2010 Brian Orelli	Is This 4,000-Liter Bioreactor Half-Full? Or half-empty? Only time will tell for Genzyme.
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 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 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 18, 2008 Brian Orelli	Genzyme Grounded for Thanksgiving The biotech won't get a decision on Myozyme until February.
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 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 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 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 October 22, 2010 Brian Orelli	No Swelling Sales Here ViroPharma saw its stellar launch of hereditary angioedema treatment Cinryze come to a standstill until it could scale up manufacturing further.
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 December 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
The Motley Fool November 10, 2009 Brian Orelli	3 Companies Looking for Gratitude Early These three small drug companies all have PDUFA dates in the next week: Cadence Pharmaceuticals... NeurogesX... Genzyme...
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 25, 2011 Brian Orelli	When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections?
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 February 3, 2010 Brian Orelli	Pfizer's Hedge Pays Off FDA wants more data from Pfizer's partner, Protalix on their treatment for Gaucher disease.
The Motley Fool October 18, 2007 Brian Orelli	Amylin: Waiting on the Future Research and development costs drag down the drug developer's bottom line. Investors, take note.
The Motley Fool November 19, 2009 Brian Orelli	This Stock Is a Train Wreck Genzyme's string of missteps has investors nervous.
The Motley Fool October 11, 2010 Brian Orelli	FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that.
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 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 August 20, 2010 Brian Orelli	This Billionaire Likes Biotech. Should You? It depends on how much you trust management.
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 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 April 24, 2008 Brian Lawler	FDA Stings Genzyme Earnings A nasty surprise hurts the drug developer's first quarter results.
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 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 December 7, 2007 Brian Orelli	Amylin's Temporarily Worthless Label Expansion Amylin releases label expansion data that won't be useful for a few years. Investors, take note.
The Motley Fool August 18, 2011 Brian Orelli	Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.
The Motley Fool March 27, 2009 Brian Orelli	The Skinny on a Triple-Decker Update Amylin's public relations department might need to go on a diet.
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 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 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 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 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 April 28, 2008 Brian Orelli	FDA Moves Isis' Finish Line The FDA tells drugmaker Isis it must complete cancer tests before submitting its marketing application.
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 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 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 March 15, 2010 Brian Orelli	Warning: Not All Boxed Warnings Are Equal Plavix's is mild in comparison.
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 December 24, 2009 Brian Orelli	Another Reason to Worry About Pfizer The FDA fails to approve Lyrica for treating anxiety.
The Motley Fool March 16, 2010 Brian Orelli	How to Lose $114 Million in One Day You've got to be a very trusting investor to buy shares in pharmaceutical company, MannKind.
The Motley Fool April 5, 2010 Brian Orelli	1 Month to Go! Is Dendreon a Buy? Only if you understand the risks.
The Motley Fool November 26, 2010 Brian Orelli	Black Friday Biotech Bargains Drugmakers on sale.