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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 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.
Managed Care November 2004 Martin Sipkoff	OTC Status for Low-Dose Lovastatin Would Have Widespread Implications The FDA stands poised to approve OTC low-dose statins, following a similar change in United Kingdom.
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 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.
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	Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency.
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.
Reason September 2005 Kerry Howley	Locking Up Life-Saving Drugs U.S. prescription laws make us sicker and poorer because the system that puts drugs over the counter is driven by profits and patents.
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 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 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 4, 2011 Brian Orelli	Anti-Infective, Very Effective The FDA seems to like Optimer's new antibiotic.
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 April 26, 2011 Luke Timmerman	FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex?
Pharmaceutical Executive April 1, 2006 Jill Wechsler	Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf?
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 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 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 November 19, 2010 Brian Orelli	Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences.
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.
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 November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
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 April 25, 2011 Luke Timmerman	Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it?
Pharmaceutical Executive July 30, 2007 Louis A. Morris	Safety Net The new Culture of Drug Safety means embracing the benefit of no doubt about a product's pluses and its minuses. Pharma must learn how patients and prescribers weigh risks and how to spread the word about the advantages.
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 April 11, 2008 Brian Lawler	Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.
The Motley Fool January 22, 2008 Brian Lawler	Adolor Under the FDA's Spotlight The FDA releases its documents on Adolor's lead drug, with surprising good news in advance of an advisory panel discussion. Investors, take note.
The Motley Fool September 16, 2010 Brian Orelli	Abbott's Product Line May Get Thinner Not that it needs the obesity drug.
Pharmaceutical Executive July 3, 2007 Louis A. Morris	Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way.
The Motley Fool January 4, 2012 Brian Orelli	Mark Your Calendars, Biotech Investors Cell Therapeutics' advisory panel meet ought to be entertaining.
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 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 6, 2005 Stephen D. Simpson	FDA's Eye on 2 Potential Blockbusters This week, FDA advisory panels will consider the marketing approval applications of Exubera, the inhaled insulin from Pfizer/Sanofi/Nektar, and Pargluva, the dual PPAR agonist, taken in pill form, from Bristol-Myers and Merck. Investors, take note.
Pharmaceutical Executive May 1, 2005 Jill Wechsler	Washington Report: The Pendulum Swings FDA cracks down on safety. Haven't we been here before? Perhaps in the end, the public will have a better understanding of the dangers associated with all pharmaceuticals and how virtually impossible it is to guarantee a risk-free medical treatment.
The Motley Fool July 15, 2010 Brian Orelli	The Blockbuster Drug Survives Another Body Blow Avandia is still standing.
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.
Pharmaceutical Executive June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
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 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
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.
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.
The Motley Fool July 14, 2010 Luke Timmerman	Vivus Faces Turning Point Tomorrow Thursday's the big day. All eyes will be on Vivus and the FDA's decision on their new obesity drug
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 December 31, 2007 Brian Lawler	Lower Expectations for Theravance The FDA decides to debate Theravance's lead drug, Telavancin, leading to a drop in share price.
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.
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
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.