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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 June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
The Motley Fool August 14, 2009 Brian Orelli |
Amgen Close to Scoring Big Amgen gets good-enough results from a FDA panel. |
The Motley Fool May 28, 2010 Brian Orelli |
This Drug Doesn't Work. But All Is Not Lost. Novartis cancer drug fails one trial, but there's still hope. |
The Motley Fool February 27, 2008 Brian Orelli |
Everyone's Picking on Anemia Drugs A new study in The Journal of the American Medical Association is adding fuel to the fire about Amgen's and Johnson & Johnson's anemia drugs. Should investors worry? |
The Motley Fool April 26, 2007 Mike Havrilla |
Dendreon Is Worth a Shot Provenge might be approved, which means investors might be rewarded. However, the massive short interest also highlights the tremendous risk in Dendreon. |
The Motley Fool December 6, 2007 Brian Lawler |
Genentech Voted Down An FDA panel recommends against expanded use of Genentech's lead drug. |
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 October 11, 2010 Brian Orelli |
A Dendreon Killer? Not Yet. Johnson & Johnson's abiraterone looks good, but won't knock off the newcomer. |
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 December 4, 2007 Brian Lawler |
Will Avastin Squeeze Past the FDA? Unless an FDA advisory panel provides extremely strong reasoning for approving Avastin on the evidence of PFS benefits alone, Genentech and its investors should expect another approvable letter come January. |
The Motley Fool June 16, 2008 Brian Orelli |
More Cancer Issues for Johnson & Johnson Potential cancer-causing side effects of Johnson & Johnson's drugs are like a tumor that continues to grow on the company. |
The Motley Fool August 31, 2009 Brian Orelli |
Good Luck, Genzyme -- You'll Need It The drugmaker faces an FDA advisory-panel showdown regarding its leukemia drug Clolar. |
The Motley Fool July 23, 2007 Brian Lawler |
GPC's Date With the FDA A document released by the FDA outlines its concerns with GPC's lead drug. Investors, take note. |
The Motley Fool October 19, 2010 Brian Orelli |
When the Status Quo Is a Big Win The lack of an FDA rejection will do just fine. Amgen and Johnson & Johnson seemed to get through the FDA advisory panel process without much problem yesterday. |
The Motley Fool September 10, 2010 Brian D. Pacampara |
A Potential Blockbuster Roars Ahead Johnson & Johnson made a good choice to purchase Cougar Biotechnology. |
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 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 4, 2011 Brian Orelli |
Up 15% for That? InterMune investors react to a non-event. |
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 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. |
Chemistry World July 16, 2010 Matt Wilkinson |
Bittersweet victory for GSK's Avandia GlaxoSmithKline has received a muted 'thumbs up' from a US regulatory advisory panel for its much-maligned Type 2 diabetes drug Avandia (rosiglitazone), making it likely the US Food and Drug Administration will allow the UK-based pharma giant to continue selling the drug in the US. |
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 April 3, 2007 Brian Lawler |
Dendreon's Positive Panel Surprise Shares of the drugmaker jump after a FDA advisory panel finds in favor of its lead cancer compound. |
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 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 April 5, 2010 Brian Orelli |
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks. |
The Motley Fool March 21, 2011 Brian Orelli |
Let's See Some Data, Curis Curis investors seem to have shrugged off the multiple unknowns and embraced the potential for the company's skin cancer drug. |
The Motley Fool July 16, 2010 Brian Orelli |
Why VIVUS Is 57% Thinner In a move that slashed the pharmaceutical's shares, Food and Drug Administration advisory committee recommended that the agency not approve their obesity drug Qnexa. |
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 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 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, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool March 4, 2010 Brian Orelli |
Best in Class ... For Now Sanofi's new prostate cancer drug is better than nothing. |
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 August 24, 2009 Brian Orelli |
J&J Would Rather Not Say Drug delayed, reason unknown. Should shareholders be worried? It's hard to tell. |
The Motley Fool June 18, 2010 Brian Orelli |
Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday. |
The Motley Fool November 1, 2011 Brian Orelli |
Not Such an Excellent Outcome With the FDA Exelixis gets knocked down for not getting an SPA. |
The Motley Fool June 23, 2010 Brian Orelli |
Duo of Diabetes Drug Deals Make J&J Better Licensing deals add to Johnson & Johnson's diabetes franchise. |
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 May 27, 2010 Brian Orelli |
This Rabid Agency Could Permanently Damage Your Portfolio The FDA has gotten a little out of control. The wonkiness of the FDA's actions makes it hard for investors to figure out what the agency will do. |
The Motley Fool December 27, 2011 Brian Orelli |
Exelixis 2011: Not What the Doctor Ordered A tale of an inability to get a Special Protocol Assessment from the FDA. |
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 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 14, 2007 Brian Lawler |
Dendreon Tries to Pick Up the Pieces Dendreon lays out its preliminary plans following a negative FDA regulatory decision. Investors shouldn't necessarily take the smashed-down share price as indicative of a possible biotech value play. |
The Motley Fool February 23, 2010 Brian Orelli |
The One That Didn't Get Away After some encouragement, the FDA approves Gilead's Cayston. |
The Motley Fool September 14, 2010 Luke Timmerman |
Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug. |
The Motley Fool July 28, 2010 Brian Orelli |
Amplifying the Risk-Reward Ratio Amplify, Medtronic's latest, gets a mixed reaction at FDA advisory panel meeting. |
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 August 10, 2007 Brian Lawler |
GPC Picking Up the Pieces GPC Biotech announced second-quarter financial results last week, in the shadow of a setback; they are awaiting more data on a crucial drug candidate. |