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The Motley Fool January 22, 2008 Brian Lawler |
Adolor Under the FDA's Spotlight The FDA releases its documents on Adolor's lead drug, with surprising good news in advance of an advisory panel discussion. Investors, take note. |
The Motley Fool November 30, 2007 Brian Lawler |
FDA Throws Adolor a Bone Pharmaceutical company Adolor gets an advisory panel hearing on its lead drug. Investors, take note. |
The Motley Fool January 24, 2008 Brian Lawler |
Adolor Advisory Panel Aftermath An FDA advisory panel votes favorably on Adolor's lead drug. |
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 September 14, 2007 Brian Lawler |
FDA Keeps Adolor Waiting Adolor and partner GlaxoSmithKline continue playing the FDA waiting game, as the agency has still not decided whether to allow clinical trials of Adolor's top drug to continue. |
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 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 12, 2008 Brian Lawler |
A Pre-Emptive Strike on the FDA Adolor will likely be waiting an extra three months for a decision on its lead drug Entereg. |
The Motley Fool June 12, 2007 Brian Lawler |
Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg. |
The Motley Fool November 8, 2006 Brian Lawler |
Stumbling Block for Adolor Another approvable letter from the FDA means investors may have to be patient. |
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 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 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 April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate. |
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 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 November 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |
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 January 25, 2007 Brian Lawler |
Discovery Finds Its Way Even though Discovery Laboratories has been in control of its manufacturing plant for only one of the approvable letters, another failure to get approval of Surfaxin will probably be strike three for most investors. |
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 March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
The Motley Fool August 29, 2007 Brian Lawler |
Adolor Stays in the Ring Adolor takes another run at getting FDA approval for its lead drug. Shares of the biotech firm are up on news the FDA had accepted for review additional information about its ileus medication, Entereg. |
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 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 August 12, 2008 Brian Lawler |
The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers? |
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 27, 2010 Brian Orelli |
FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered. |
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 December 9, 2008 Brian Orelli |
Presents or Coal From the FDA? Let's take a look at a few companies expecting FDA decisions this month and see whether they're more likely to get a present or a lump of coal in their marketing-application stockings. |
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 11, 2007 Brian Lawler |
Adolor: Down and Out? The drug developer announces dour clinical trial results. Shares of Adolor crashed nearly 60% on the news. |
The Motley Fool March 27, 2008 Brian Lawler |
A Drugmaker's Candid Thoughts on the FDA Cardiome updates investors on its top two drugs. |
The Motley Fool September 17, 2010 Brian Orelli |
Thanks for Nothing, Fen-Phen Arena gets knocked down despite a relatively clean side-effect profile. |
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 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 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 September 5, 2006 Brian Lawler |
Adolor: Positive Results, Negative Reaction The market seems confused by good results from Adolor's latest clinical trial. Investors willing to take a gamble on Adolor at this price may be in for huge rewards if the company and Glaxo can convince the FDA of Entereg's viability. |
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 April 25, 2008 Brian Orelli |
Progenics' Double Dose of Good News Its lead drug gets FDA approval and a positive EU recommendation. |
The Motley Fool May 30, 2008 Brian Orelli |
No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil. |
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 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 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. |
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 April 7, 2011 Brian Orelli |
Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market. |
The Motley Fool February 28, 2007 Brian Lawler |
Discovery Prepares for Its Fate Discovery Labs announces its quarterly financial results as it prepares for another meeting with the FDA. Investors, take note. |
The Motley Fool May 9, 2007 Brian Lawler |
Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note. |
The Motley Fool December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
The Motley Fool April 26, 2011 Luke Timmerman |
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex? |
The Motley Fool October 11, 2010 Brian Orelli |
FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that. |