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The Motley Fool December 12, 2007 Brian Lawler |
No Shock for Cardiome An FDA advisory panel gives the nod to Cardiome's heart drug. Investors, take note. |
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 March 18, 2008 Brian Lawler |
Cardiome's Yin and Yang Cardiome reports positive mid-stage data for its irregular heartbeat drug. |
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 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 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 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 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 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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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 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 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 September 29, 2011 Brian Orelli |
Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA. |
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 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 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 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 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 June 18, 2010 Brian Orelli |
Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday. |
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 June 20, 2011 Brian Orelli |
See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely. |
The Motley Fool June 16, 2011 Brian Orelli |
Are Two FDA Approvals in One Week a Positive Sign? Bristol-Myers Squibb received Food and Drug Administration approval for its kidney transplant drug Nulojix yesterday, marking the second approval this week from 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 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 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 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
The Motley Fool August 14, 2008 Brian Lawler |
A Potentially Painless PDUFA Date King Pharmaceuticals and Pain Therapeutics get an appointment with the FDA. |
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 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 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 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. |
The Motley Fool April 13, 2009 Brian Orelli |
Will These Drugs Get Past the FDA? Hopefully April won't bring showers of tears to these drugmakers: Eli Lilly... AstraZeneca... Bristol-Myers Squibb... Novo Nordisk... Johnson & Johnson... |
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 16, 2009 Brian Orelli |
Music to Health-Care Investors' Ears Are faster FDA review times coming? |
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 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 June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee 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 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 January 31, 2007 Brian Lawler |
FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer. |
The Motley Fool April 7, 2011 Brian Orelli |
Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market. |
The Motley Fool February 3, 2010 Brian Orelli |
Pfizer's Hedge Pays Off FDA wants more data from Pfizer's partner, Protalix on their treatment for Gaucher disease. |
The Motley Fool August 27, 2010 Brian Orelli |
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. |
The Motley Fool December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
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 June 21, 2007 Brian Lawler |
Pfizer Gets Held Up The FDA issues an approvable letter for its novel HIV compound. Investors, take note. |
The Motley Fool November 29, 2010 Brian Orelli |
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain. |