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The Motley Fool June 16, 2011 Brian Orelli |
No Poke in the Eye Here What's the biggest sign that the Food and Drug Administration is all set to approve Regeneron Pharmaceuticals' Eylea? The briefing documents for the advisory committee contained a proposed version of the label. |
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 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 August 22, 2011 Brian Orelli |
Speedy in Seattle Seattle Genetics gets an early approval of Adcentris. |
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 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 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 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 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 April 1, 2011 Travis Hoium |
Optimer Pharmaceuticals Shares Popped: What You Need to Know Shares of Optimer Pharmaceuticals jumped 12% today after positive news from the FDA was released. |
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 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 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 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 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 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 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 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 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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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 April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate. |
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 November 19, 2010 Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. |
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 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 November 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |
The Motley Fool June 2, 2008 Brian Lawler |
Ligand's Hail-Mary Touchdown The drugmaker receives an unexpected advisory-panel surprise regarding its lead drug, Promacta. |
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 May 5, 2008 Brian Lawler |
Good News for Abuse-Resistant Drugs Drug developers working on harder-to-abuse pain remedies, including Pain Therapeutics, King Pharmaceuticals, and Alpharma, got a guarded thumbs-up from the FDA last week. |
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 April 28, 2011 Brian Orelli |
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval. |
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 January 4, 2012 Brian Orelli |
Mark Your Calendars, Biotech Investors Cell Therapeutics' advisory panel meet ought to be entertaining. |
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 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 December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
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 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 April 4, 2011 Brian Orelli |
Anti-Infective, Very Effective The FDA seems to like Optimer's new antibiotic. |
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 February 28, 2008 Brian Lawler |
FDA's Mixed Signals for Theravance The FDA gives Theravance frustrating double messages about a lead drug. |
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 October 11, 2010 Brian Orelli |
What Meridia's Demise Means for Arena, VIVUS, and Orexigen Safety first ... and second ... and third... |
The Motley Fool December 14, 2007 Brian Lawler |
Ignore the Dendreon Hoopla A Congressional probe request will have no effect on Dendreon or Provenge's odds at making it through the FDA, since it was not the FDA reviewers of the Provenge marketing application that were accused of anything bad. |
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 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 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 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 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. |