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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 13, 2009 Brian Orelli	Will These Drugs Get Past the FDA? Let's take a look at which pharma companies are hoping to score with the FDA this month.
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 December 27, 2010 Brian Orelli	FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered.
The Motley Fool July 16, 2008 Brian Lawler	A Big Move From ViroPharma ViroPharma picks up an asset that's more than half its size.
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 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 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 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 December 28, 2010 Brian Orelli	Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson.
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 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 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 October 11, 2010 Brian Orelli	FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that.
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 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 November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
The Motley Fool February 25, 2011 Brian Orelli	Minor Delay, Major Missed Opportunity Protalix and Pfizer's Gaucher disease drug gets delayed.
Chemistry World November 4, 2015 Phillip Broadwith	Shire to buy cardiovascular specialist Dyax The deal gives Shire access to Dyax's portfolio of approved and developmental drugs for treating hereditary angioedema.
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 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 August 31, 2011 Brian Orelli	Shire Enters a Crowded Market Last week, the FDA approved Shire Pharmaceuticals' Firazyr to treat a rare genetic disease.
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 November 30, 2009 Brian Orelli	The FDA Moves the Goalposts The FDA sends a complete response letter to Theravance about its antibiotic Vibativ, which it's trying to get approved for treating patients with nosocomial pneumonia.
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 February 14, 2008 Brian Orelli	Drug Developer Displays Its Goods Dyax strikes a licensing deal with Sanofi-Aventis, sending shares soaring. Investors, take note.
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 November 18, 2008 Brian Orelli	Genzyme Grounded for Thanksgiving The biotech won't get a decision on Myozyme until February.
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 December 31, 2007 Brian Lawler	Lower Expectations for Theravance The FDA decides to debate Theravance's lead drug, Telavancin, leading to a drop in share price.
The Motley Fool December 3, 2009 Brian Orelli	I Love This Industry With double-digit gains, how could you not love the biotech industry?
The Motley Fool December 15, 2006 Brian Lawler	Reformatting Encysive Yet another delay from the FDA leaves investors hanging.
The Motley Fool June 25, 2008 Brian Lawler	Why the Lilly Delay, FDA? A government review of the company's top drug candidate gets pushed back.
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 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 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 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 31, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.
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 March 19, 2009 Brian Orelli	One Down, One to Go Sanofi-aventis slides past an FDA panel and hopes for more good news today
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 December 31, 2008 Brian Orelli	An Imminent Drug Approval? Really? Lilly may finally hear about prasugrel.
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 November 16, 2009 Brian Orelli	Music to Health-Care Investors' Ears Are faster FDA review times coming?
The Motley Fool May 20, 2010 Brian Orelli	FDA Transparency! A Big Win for Investors The Food and Drug Administration has possibly just made things easier for investors. Let's just hope drug companies don't shoot it down.
The Motley Fool December 8, 2010 Brian Orelli	Up 100% With Room to Fly Orexigen gets a positive FDA panel nod.
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 November 24, 2010 Sean Williams	ViroPharma: Bargain or Value Trap? Generic competition and production issues are major red flags.