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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 9, 2010 Brian Orelli |
2 Days, 1 Blockbuster, Fate Unknown GlaxoSmithKline heads before a marathon two-day Food and Drug Administration advisory panel review of its diabetes drug Avandia. |
The Motley Fool July 8, 2008 Brian Lawler |
Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards. |
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 April 10, 2008 Brian Lawler |
Glaxo Angers the FDA GlaxoSmithKline announces that the FDA has sent it a warning letter regarding its failure to meet certain post-marketing requirements for Avandia. |
Chemistry World September 24, 2010 Andrew Turley |
End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use. |
Chemistry World July 31, 2007 Victoria Gill |
FDA Advised: Avandia Should Stay on the Market The US Food and Drug Administration's (FDA's) Advisory Committee came to an almost unanimous decision yesterday for Avandia, GlaxoSmithKline's much-maligned diabetes treatment, to remain on the US market. |
The Motley Fool May 22, 2007 Mike Havrilla |
Avandia Safety Concerns Weigh Down Glaxo Shares of GlaxoSmithKline dropped nearly 8%, after a study raised safety concerns about the company's widely used diabetes drug, Avandia. |
Chemistry World May 22, 2007 Victoria Gill |
GSK Drug's Safety Questioned A prominent US clinician has concluded that a diabetes drug produced by UK pharmaceutical company GlaxoSmithKline increases the risks of heart attack and death. |
Chemistry World February 26, 2010 Sarah Houlton |
Report hits out at GSK's Avandia GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) has been dealt another blow, with the publication of a report by two US senators claiming the company knew about safety problems long before they reached the public domain. |
The Motley Fool February 22, 2010 Brian Orelli |
Warning: Avandia Could Cause Drool Among Trial Lawyers An unintended side effect of Glaxo's Avandia might be excessive salivation among trial lawyers. A 342-page report by the Senate Finance Committee is painting the diabetes drug in a not-so-great light. |
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 June 29, 2010 Brian Orelli |
Diabetes Drug Development Pops and Drops When companies present at a major meeting, there's bound to be both. |
The Motley Fool June 12, 2007 Michael P. Cecil |
When Dr. Nissen Talks ... Congress and the FDA listen. The Avandia story is just beginning, and drug-safety issues were hard on the share prices of Merck when Vioxx was in the news, as well as Pfizer when torcetrapib was taken off the market. |
The Motley Fool July 15, 2010 Brian Orelli |
The Blockbuster Drug Survives Another Body Blow Avandia is still standing. |
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 June 8, 2009 Brian Orelli |
For the RECORD... Avandia's not going to make a comeback for GlaxoSmithKline. |
Pharmaceutical Executive July 30, 2007 Richard Altus |
Avandia Sales Away What did you do when you heard the safety news about Avandia? Here's what the rest of the market did, and why it matters to you. |
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 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 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 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 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 August 18, 2010 Brian Orelli |
No Pain Here as Jazz Shares Rocket Investors are all jazzed up about Jazz Pharmaceuticals |
The Motley Fool July 26, 2007 Brian Lawler |
Glaxo Getting Through Avandia Loss Glaxo's earnings aren't hurt by the decline in Avandia sales. When excessive fears start to bring down shares of a drugmaker with good sales-growth potential over the long run, smart investors should see a buying opportunity. |
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 April 29, 2010 Brian Orelli |
Earnings Up 17%, but Here's Why You Should Be Worried One-time sales are no way to run a pharmaceutical business. |
The Motley Fool June 14, 2007 Brian Lawler |
Dueling Fools: GlaxoSmithKline Bull Shares of the pharmaceutical may be temporarily down, but it's not out. |
Chemistry World July 2007 Victoria Gill |
Conflict of interest? The FDA has been questioned after a published study brought exposed cardiovascular risks associated with GlaxoSmithKline's diabetes drug, Avandia. |
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 31, 2008 Brian Lawler |
Who Let the Docs Out? A leaked, confidential journal article could get Glaxo in hot water. |
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 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 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 June 3, 2011 Luke Timmerman |
Orexigen, Facing High Hurdle at FDA, Puts Obesity Drug Development on Hold The close attention paid to safety makes this drug difficult to get right. |
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 September 16, 2010 Brian Orelli |
Abbott's Product Line May Get Thinner Not that it needs the obesity drug. |
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 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 April 2, 2009 Brian Orelli |
A Diabetic Compromise Bristol-Myers and AstraZeneca will have to test their drug after it goes on the market. |
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 December 3, 2010 Brian Orelli |
Obesity Drug Companies Are (Still) Risky Orexigen heads before an FDA panel. |
Pharmaceutical Executive July 3, 2007 Walter Armstrong |
Back Page: Oh Man, Avandia Think you know the Avandia story? Pharma execs should take this test to see what they missed. |
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 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. |
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 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 8, 2008 Brian Orelli |
A Checkup for Makers of Asthma Drugs Because of recent events, GlaxoSmithKline, AstraZeneca, Novartis, and Schering-Plough all face extra scrutiny from the FDA. |
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. |