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The Motley Fool August 20, 2011 Luke Timmerman |
Seattle Genetics Wins FDA Approval of First Drug FDA gives a quick turnaround on the new treatment for lymphomas. |
The Motley Fool July 13, 2011 Brian Orelli |
2 Questions for Seattle Genetics So far the FDA is fairly impressed with Seattle Genetics' lymphompa drug brentuximab vedotin. |
The Motley Fool July 14, 2011 Luke Timmerman |
Seattle Genetics Wins Unanimous OK for Lymphoma Drug from FDA Panel An FDA panel of cancer drug experts recommended in a 10-0 vote that the company's drug for Hodgkin's lymphoma should be cleared for sale in the U.S. |
The Motley Fool August 22, 2011 Brian Orelli |
Speedy in Seattle Seattle Genetics gets an early approval of Adcentris. |
The Motley Fool September 27, 2010 Brian Orelli |
Now That's What I Call a Drug That Works Seattle Genetics hits a home run -- and then some -- with its cancer drug Brentuximab vedotin. |
The Motley Fool July 5, 2011 Luke Timmerman |
Seattle Genetics, on the Verge of Going Commercial, Seeks to Keep Its Scientific Soul Expectations are sky-high. |
The Motley Fool July 15, 2011 Brian Orelli |
Seattle Genetics Will Work It Out This isn't the NFL labor negotiations. |
The Motley Fool December 29, 2011 Brian Orelli |
What to Look For With Seattle Genetics in 2012 The launch of its new drug Adcetris will be key. |
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 June 20, 2011 Brian Orelli |
See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely. |
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 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 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 October 12, 2010 Brian Orelli |
Clinical Trial Positive! Shares Just Barely A story about expectations. Seattle Genetics is two for two in recent weeks. |
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 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 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 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |
The Motley Fool April 25, 2011 Luke Timmerman |
Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it? |
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. |
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. |
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 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 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 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 February 9, 2007 Brian Lawler |
Picking Up the Pace at Seattle Genetics The cash situation shows the shares of this drug development company could be appealing. |
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 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 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 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 September 10, 2007 Brian Lawler |
Get a Glimpse of Amgen's Future Investors will want to pay attention to an FDA advisory panel meeting discussing new labeling recommendations for Amgen's anemia medications. The two drugs represented 44% of the pharmaceutical company's second-quarter revenue. |
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 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 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 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 January 4, 2012 Brian Orelli |
Mark Your Calendars, Biotech Investors Cell Therapeutics' advisory panel meet ought to be entertaining. |
The Motley Fool March 31, 2011 Brian Orelli |
Better Buy? Seattle Genetics or ImmunoGen Battle of the heat-seeking cellular missiles. |
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 July 14, 2010 Luke Timmerman |
Vivus Faces Turning Point Tomorrow Thursday's the big day. All eyes will be on Vivus and the FDA's decision on their new obesity drug |
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 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 November 19, 2010 Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. |
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 September 6, 2005 Stephen D. Simpson |
FDA's Eye on 2 Potential Blockbusters This week, FDA advisory panels will consider the marketing approval applications of Exubera, the inhaled insulin from Pfizer/Sanofi/Nektar, and Pargluva, the dual PPAR agonist, taken in pill form, from Bristol-Myers and Merck. 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 November 29, 2011 Brian Orelli |
Winners and Losers of Roche's Avastin Woes What the FDA giveth, the FDA can taketh away. |
The Motley Fool June 8, 2010 Brian Orelli |
Injecting Uncertainty Into the Multiple Sclerosis Market Novartis' oral MS drug could be a blockbuster -- if it can get past the FDA. |
The Motley Fool September 14, 2010 Brian Orelli |
This Bad News Could've Been Worse A Seattle Genetics drug fails, but there's more in the pipeline. |
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 September 28, 2011 Brian Orelli |
One Step Closer to an FDA Decision Cell Therapeutics is still risky, though. |