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The Motley Fool April 16, 2008 Brian Lawler |
Cephalon Convinces the Continent The pharmaceutical's lead pain drug gets approved for marketing in Europe. |
The Motley Fool September 14, 2007 Brian Lawler |
"Dear Doctor" Letter Spells Trouble for Cephalon Cephalon sends a letter to health-care practitioners warning of the dangers of misusing one of its lead drugs, Fentora. Investors, take note. |
The Motley Fool September 27, 2007 Brian Lawler |
FDA Repeats Itself With Cephalon's Fentora In the wake of a letter from Cephalon to health-care practitioners, the FDA has issued a press release and a public health advisory of the dangers of misusing the company's pain drug Fentora. Investors, take note. |
The Motley Fool September 26, 2006 Brian Lawler |
A Savior for Cephalon? The FDA's approval of Fentora comes just in time for the drug company. 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 October 11, 2010 Brian Orelli |
FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that. |
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 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 March 19, 2009 Brian Orelli |
One Down, One to Go Sanofi-aventis slides past an FDA panel and hopes for more good news today |
The Motley Fool July 6, 2006 Brian Lawler |
Cephalon on the Hunt The biopharma company is looking to make more acquisitions and gets some good news from the FDA. Cephalon's stock climbed by more than 10% after the announcement. |
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 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 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 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 4, 2008 Brian Lawler |
Sitting Tight in September This month, several drugmakers will hear about compounds awaiting approval, so we can expect some volatility in their share prices. Read on to see who's awaiting FDA news. |
The Motley Fool August 18, 2010 Brian Orelli |
More Pain Ahead for Eli Lilly? An advisory panel meeting tomorrow could further the company's slide. |
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 March 24, 2006 Brian Gorman |
Cephalon Takes a Hit The FDA rules against its ADHD drug, but Cephalon's current lineup still holds promise. Investors may want to look at the current sell-off as a potential buying opportunity. |
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 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 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 4, 2004 Charly Travers |
Drug Growth Screeching to a Halt Given the threat of generics to not-so-small drug company Cephalon's product line, the acquisition of CIMA labs in August of this year could turn out to be quite important. |
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 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 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 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 16, 2010 Brian Orelli |
Abbott's Product Line May Get Thinner Not that it needs the obesity drug. |
The Motley Fool November 22, 2006 Brian Lawler |
How to Market a Drug Too Well Cephalon's promotion of its pain drug Actiq might have crossed the line. |
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 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 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 June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
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 November 19, 2010 Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. |
The Motley Fool July 31, 2007 Brian Lawler |
Avandia Can Stay An FDA advisory panel votes to allow GlaxoSmithKline's top diabetes compound, Avandia, to remain on the market. |
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 27, 2007 Brian Lawler |
Cephalon's Earnings Surprise The drugmaker raises its earnings guidance for the year. With no serious competition for its lead compounds in the near term, investors should take a look at the well-run pharma. |
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 July 16, 2010 Luke Timmerman |
Vivus Obesity Drug Shot Down by FDA Panel Vivus suffered a setback today at an important meeting for the future of obesity drug development, with implications for Arena Pharmaceuticals and Orexigen Therapeutics. |
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 July 11, 2008 Brian Orelli |
Pfizer Looking at a Level Playing Field An advisory panel says that epilepsy drugs don't need a black-box warning, news that is positive for drug companies -- that is, those other than Pfizer. |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
The Motley Fool December 14, 2007 Brian Orelli |
Panel Kills Merck's Hope of OTC Status An FDA advisory panel isn't convinced that Merck's cholesterol-lowering drug MEVACOR deserves OTC status. |
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 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 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 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 February 18, 2010 Brian Orelli |
Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance. |
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. |