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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 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 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 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 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 May 17, 2007 Brian Lawler |
MedImmune Gets the Thumbs-Up An advisory panel recommends expanded use for one of MedImmune's drugs. |
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 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 September 16, 2010 Brian Orelli |
Abbott's Product Line May Get Thinner Not that it needs the obesity drug. |
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 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 May 20, 2011 Brian Orelli |
Abbott Hits a Triple Not a home run, but Trilipix will likely stay on the market. |
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 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 September 5, 2008 Brian Orelli |
Zimmer Fortifies Its Spine The medical-device maker is buying Abbott's spine business. |
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 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 June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
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 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 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 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 July 16, 2009 Brian Orelli |
Keep Your Chin Up, J&J An FDA advisory committee smacked down its drug candidate. |
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 February 5, 2008 Brian Orelli |
Medtronic Endeavors to Compete The U.S. drug-eluting stent market just got a little more crowded, after Medtronic announces that the FDA had approved its Endeavor stent for marketing in the U.S. |
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 February 27, 2009 Brian Orelli |
Get a Life, Congress! A Congressional investigation into whether the FDA was right to pull a doctor off of the advisory panel for Eli Lilly's blood thinner prasugrel illustrates why Congress needs to keep its nose out of scientific discussions. |
The Motley Fool August 10, 2010 Brian Orelli |
When the Disease Matters Most in Drug Approval Glaxo's and Valeant's Potiga will go before an FDA advisory committee tomorrow. |
The Motley Fool June 11, 2010 Brian Orelli |
25 to 0! Now That's a Ringing Endorsement Novartis flies through its advisory panel meeting nearly unscathed. |
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 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 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 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 September 7, 2011 Brian Orelli |
J&J and Bayer Head in Front of the Firing Squad An expanded indication for Xarelto seems unlikely. |
The Motley Fool September 14, 2010 Brian Orelli |
42% Drop? Really? Tell Us Something We Didn't Know. Arena Pharmaceuticals gets knocked down for no good reason. |
The Motley Fool October 22, 2009 Brian Orelli |
Good Luck in 2010, Amgen Just when it looked like Amgen was turning things around the Food and Drug Administration threw a wrench in the biotech's plans for its osteoporosis drug Prolia. |
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 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 August 20, 2010 Brian Orelli |
Depression Is Painful. Advisory Panels More So. Eli Lilly's Cymbalta has a rough time in from of the panel of experts. |
The Motley Fool July 7, 2008 Brian Orelli |
And Then There Were 4 The number of drug-eluting stent players in the U.S. doubles with the addition of Medtronic's Endeavor and Abbott Labs' Xience V. |
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 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 March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
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 December 10, 2008 Brian Orelli |
A Painless Advisory Panel Meeting Genzyme might be getting a Christmas present from the Food and Drug Administration. An FDA advisory panel unanimously recommended approval for Genzyme's osteoarthritis pain drug Synvisc-One. |
The Motley Fool November 28, 2007 Brian Orelli |
Abbott's Future as a Stent Maker The FDA likes Abbott's new drug-eluting stent; it seems likely the advisory committee will recommend that it be approved. |
The Motley Fool February 25, 2010 Brian Orelli |
Transplanting Future Revenue Bristol-Myers Squibb waits for experts to decide the fate of its kidney cancer drug. |
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 2, 2009 Brian Orelli |
A Diabetic Compromise Bristol-Myers and AstraZeneca will have to test their drug after it goes on the market. |