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The Motley Fool March 18, 2008 Brian Lawler	Cardiome's Yin and Yang Cardiome reports positive mid-stage data for its irregular heartbeat drug.
The Motley Fool March 27, 2008 Brian Lawler	A Drugmaker's Candid Thoughts on the FDA Cardiome updates investors on its top two drugs.
The Motley Fool November 14, 2007 Brian Lawler	Busy Times Ahead for Cardiome Keep an eye on Canadian drug developer Cardiome Pharma over the next three months; its entire pipeline of drugs will be receiving regulatory scrutiny during this time.
The Motley Fool November 27, 2007 Brian Lawler	Cardiome Makes Them Wait Cardiome Pharma announces a delay in the release of data on an oral version of its lead heart drug. Investors, take note.
The Motley Fool August 12, 2008 Brian Lawler	The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers?
The Motley Fool September 13, 2007 Brian Lawler	Cardiome at a Glance Cardiome Pharma gives investors an overview of where its lead Cardiac drug stands; a New Drug Application has been submitted to the FDA.
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 May 15, 2008 Brian Lawler	You're Kidding Me, Cardiome! Canadian pharmaceutical company Cardiome is still awaiting an FDA decision on its lead drug.
The Motley Fool August 28, 2007 Andrew R. Vaino	Cardiome's Hearty Outlook If the FDA renders a favorable decision on an anti-fibrillation drug, Cardiome's heart may well skip a beat. As with any investment based on FDA approval, of course, there is substantial risk involved.
The Motley Fool July 27, 2011 Brian Orelli	Switching Partners Provides a Big Shot in the Arm Merck loves Cardiome more than Astellas does.
The Motley Fool April 9, 2009 Brian Orelli	Cash: The Cure for Smaller Drugmakers For $60 million and a credit line of an additional $100 million, Merck licenses the rights to the oral formulation of vernakalant, Cardiome's atrial fibrillation treatment.
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 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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool September 9, 2011 Brian Orelli	Firing Squad, It Was Not J&J and Bayer get through their advisory panel with minimal problems.
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 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 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 April 29, 2008 Brian Orelli	Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month.
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 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 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 April 11, 2008 Brian Lawler	Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.
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 May 1, 2007 Brian Lawler	Cardiome Plays Dealmaker Cardiome signs a deal to develop one of Eli Lilly's drug candidates. Investors, take note.
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 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 January 14, 2008 Brian Lawler	Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure.
The Motley Fool August 17, 2007 Brian Orelli	Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully.
The Motley Fool February 16, 2010 Brian Orelli	For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward.
The Motley Fool September 30, 2008 Brian Lawler	No Approval for You ... Yet The FDA makes Eli Lilly wait for word on a lead drug.
The Motley Fool December 31, 2007 Brian Lawler	The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency.
The Motley Fool December 15, 2006 Brian Lawler	Reformatting Encysive Yet another delay from the FDA leaves investors hanging.
The Motley Fool January 28, 2011 Brian Orelli	Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result.
The Motley Fool December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool November 3, 2009 Brian Orelli	A Little Distracted, Are You, Merck? The FDA rejects its latest application.
The Motley Fool July 30, 2010 Brian Orelli	A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs.
The Motley Fool September 14, 2010 Luke Timmerman	Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug.
The Motley Fool December 31, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.
BusinessWeek June 12, 2006 Catherine Arnst	Going From The Lab To Limbo The FDA has been delaying decisions on applications, and drugmakers are fuming.
The Motley Fool March 31, 2008 Brian Lawler	FDA Commish Joins Blogosphere Andrew von Eschenbach, the FDA's chief, starts a weekly blog.
The Motley Fool September 29, 2011 Brian Orelli	Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA.
The Motley Fool November 14, 2007 Brian Lawler	Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years.
The Motley Fool May 20, 2010 Brian Orelli	FDA Transparency! A Big Win for Investors The Food and Drug Administration has possibly just made things easier for investors. Let's just hope drug companies don't shoot it down.
The Motley Fool December 5, 2007 Brian Lawler	The FDA Says It Needs a Pep Pill Drugmakers offering new treatments might be discouraged by the FDA's latest report, in which the agency makes its case for additional funding from Congress.
The Motley Fool October 5, 2011 Brian Orelli	1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response.
Pharmaceutical Executive February 1, 2011 Jill Wechsler	Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency
The Motley Fool June 3, 2009 Brian Orelli	No More Triple-Digit Returns? If FDA decisions could be predicted easily, investors might not get to enjoy triple-digit returns, so perhaps we shouldn't be too upset about the tight-lipped nature of 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.
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?