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The Motley Fool June 20, 2011 Brian Orelli |
See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely. |
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 May 13, 2011 Brian Orelli |
FDA Advisory Panel Positive! Shares Punished. Despite the positive recommendation, investors aren't convinced BioMimetic's Augment will be approved. |
The Motley Fool November 19, 2010 Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. |
The Motley Fool August 18, 2011 Brian Orelli |
A Poke in the Eye From the FDA FDA extends its review of Regeneron Pharmaceuticals' macular degeneration drug by three months. |
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 November 23, 2010 Brian Orelli |
Less of a Poke in the Eye Regeneron Pharmaceuticals was up nearly 20% yesterday after the drugmaker announced the results for two phase 3 trials testing VEGF Trap-Eye in wet AMD patients. |
The Motley Fool June 17, 2009 Brian Orelli |
Savient Saves and Moves Up The FDA advisory panel gives Savient's Krystexxa a passing grade. |
The Motley Fool August 22, 2011 Brian Orelli |
Speedy in Seattle Seattle Genetics gets an early approval of Adcentris. |
The Motley Fool November 12, 2010 Brian Orelli |
Benlysta: Not Perfect, but Good Enough Human Genome should get past the FDA advisory panel next week. |
The Motley Fool November 29, 2007 Brian Lawler |
Another Chapter in Glaxo's Relenza Saga An FDA advisory panel suggested that the Relenza label should be strengthened to include the possibility of abnormal behavior and hallucinations in those who take it. |
The Motley Fool January 11, 2012 Brian Orelli |
A Year's Worth of Sales in 1 Month Regeneron's Eylea hits the gates running. |
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 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 March 19, 2007 Brian Lawler |
Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. Investors, take note. |
The Motley Fool April 28, 2011 Brian Orelli |
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval. |
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 August 1, 2007 Brian Lawler |
Elan Gets a Vote of Confidence Elan receives some good news from an FDA advisory panel in the form of a recommendation to expand the use of Tysabri to treat Crohn's disease. |
The Motley Fool December 12, 2007 Brian Lawler |
No Shock for Cardiome An FDA advisory panel gives the nod to Cardiome's heart drug. 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 May 25, 2011 Brian Orelli |
Optimer's Upcoming FDA Decision: Memorable or Memorial? We'll know on Memorial Day, plus or minus a few days. |
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 10, 2007 Brian Lawler |
Will the FDA Clear Cardiome? The agency prepares to debate Cardiome's lead drug candidate, Vernakalant, a treatment for abnormal heart rhythms. Investors, take note. |
The Motley Fool August 21, 2008 Brian Orelli |
Johnson & Johnson Gets Rejected The FDA rejects Johnson & Johnson's bid to expand the label of its antibiotic. |
The Motley Fool September 10, 2008 Brian Lawler |
A Pfizer Drug With a Cloudy Future The company offers another drug with mixed odds to the FDA. |
The Motley Fool December 11, 2009 Brian Orelli |
Gilead Gets the Experts on Its Side An advisory committee says yes after the FDA said no. |
The Motley Fool September 2, 2011 Brian D. Pacampara |
Regeneron Pharmaceuticals Shares Jumped: What You Need to Know Shares of drugmaker Regeneron Pharmaceuticals popped 10% in intraday trading Friday after The New York Times reported that Roche's age-related macular degeneration treatment Avastin led to vision loss in several California patients. |
The Motley Fool December 8, 2011 Brian Orelli |
A Soaring Biotech With Room to Run Affymax gets a leg up from an FDA advisory panel vote. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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 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 November 19, 2011 Luke Timmerman |
Regeneron Wins FDA Approval for Macular-Degeneration Drug The company can begin selling Eylea, which treats the leading cause of blindness in the elderly. |
The Motley Fool April 4, 2011 Brian Orelli |
Anti-Infective, Very Effective The FDA seems to like Optimer's new antibiotic. |
The Motley Fool May 7, 2008 Brian Lawler |
Cephalon's Long Shot Falls Short An FDA advisory panel brings bad news for the company. |
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 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
The Motley Fool December 5, 2005 W.D. Crotty |
Cashing In on Noven's Drug Patch An FDA advisory panel recommends approval of Noven's patch for attention deficit hyperactivity. For now, investors might be put off by the company's lofty valuation of 55 times trailing earnings. |
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 April 13, 2011 Brian Orelli |
Drug Duo Escapes Advisory Panel Unharmed Pfizer and Novartis are on their way to expanding their cancer drug indications. |
The Motley Fool August 18, 2010 Brian Orelli |
No Pain Here as Jazz Shares Rocket Investors are all jazzed up about Jazz Pharmaceuticals |
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 January 24, 2008 Brian Lawler |
Adolor Advisory Panel Aftermath An FDA advisory panel votes favorably on Adolor's lead drug. |
The Motley Fool September 16, 2010 Brian Orelli |
Abbott's Product Line May Get Thinner Not that it needs the obesity drug. |
The Motley Fool September 14, 2010 Brian Orelli |
42% Drop? Really? Tell Us Something We Didn't Know. Arena Pharmaceuticals gets knocked down for no good reason. |
The Motley Fool July 25, 2007 Brian Lawler |
GPC Must Wait An advisory panel recommends against approving GPC's lead drug right now. Investors, take note. |
The Motley Fool March 17, 2008 Brian Lawler |
The Panelling on Amgen's Walls One FDA panel ruling is a win, another is much less upsetting than investors feared. |
The Motley Fool July 12, 2011 Luke Timmerman |
Seattle Genetics' New "Empowered Antibody" Looks Clean in FDA Staff Documents FDA reviews Seattle Genetics' Hodgkin's lymphoma drug. |
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 September 7, 2007 Brian Orelli |
Merck Says No to This Protein An FDA advisory panel recommends unanimous approval of a new HIV drug from Merck. The new class of HIV medications fight the virus by blocking one key protein from entering cells. |