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The Motley Fool September 28, 2011 Brian Orelli |
One Step Closer to an FDA Decision Cell Therapeutics is still risky, though.  |
The Motley Fool June 15, 2011 Brian Orelli |
Investors Need a Peephole Into FDA Offices Cell Therapeutics is gung ho about its resubmission, but investors only get one side of the story.  |
The Motley Fool May 4, 2011 Brian Orelli |
Cell Therapeutics: Denied but Not Rejected Cell Therapeutics' ball may be headed for the end zone, but the FDA has an eight-foot free safety ready to bat it down.  |
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 November 19, 2010 Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences.  |
The Motley Fool September 15, 2010 Brian Orelli |
Cell Therapeutics Goes for Broke If Cell Therapeutics can't get new funding soon, long-term consequences may be the least of its worries; time on the clock looks to be running out.  |
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 December 31, 2011 David Williamson |
2011 Review: Cell Therapeutics After starting the year at a split-adjusted $2.22 a share, Cell Therapeutics stock lost almost 50% of its value by the end of December, closing at $1.16. How did we get here?  |
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 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 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 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 September 17, 2010 Luke Timmerman |
Cell Therapeutics OK'd to Sell Shares to Stay Alive Is the company being straight with shareholders?  |
The Motley Fool July 1, 2011 Brian Orelli |
What Will Cell Therapeutics Do With Your Money? Unfortunately the answer is probably, "buying a drug."  |
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 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 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 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 26, 2011 Brian Orelli |
Closer to Approval, Now Can MELA Find Customers? The restrictions might be too much. The company has been fighting for years to gain Food and Drug Administration approval of its melanoma detection device, MelaFind.  |
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 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 31, 2011 Brian Orelli |
3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012.  |
The Motley Fool May 27, 2011 Brian Orelli |
What Kind of Phase 2 Drug Can You Get for $5 Million? Cell Therapeutics issues a press release saying the company has identified a potential acquisition opportunity that is a phase II drug candidate.  |
The Motley Fool July 29, 2011 Sean Williams |
Another Day, Another Loss For Cell Therapeutics Cell Therapeutics is giving shareholders that sinking feeling.  |
The Motley Fool June 2, 2004 W.D. Crotty |
FDA's Kiss of Life The FDA ignores its advisory committee and approves Allos' new drug.  |
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 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 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 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 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 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 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 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 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 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 April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.  |
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 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 June 15, 2005 Brian Gorman |
Cell Therapeutics' Gamble The biotech company's struggles are far from over. Without an approved drug on the market or the certainty of FDA clearance, the firm won't have an easy time finding investors.  |
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 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 December 5, 2011 Brian Orelli |
Up 20%, but Uncertainty Still Looms Affymax is still a risky bet.  |
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 January 4, 2012 Brian Orelli |
This Biotech's Obese To-Do List Is Done Arena resubmits lorcaserin for FDA approval.  |
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 6, 2007 Brian Lawler |
Genentech Voted Down An FDA panel recommends against expanded use of Genentech's lead drug.  |
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 December 23, 2011 Selena Maranjian |
3 Biotech Stocks That Had a Bad 2011 It's a volatile business, and these biotechs got the short end of the stick.  |
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.  |