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The Motley Fool May 15, 2008 Brian Orelli |
Wanted: FDA Approval -- Pronto Teva and Amphastar have the courts on their side, but the FDA still stands in the way of a generic-drug launch. |
The Motley Fool March 23, 2010 Brian Orelli |
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma. |
The Motley Fool November 8, 2007 Charly Travers |
BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent. |
The Motley Fool November 7, 2007 Brian Orelli |
Momenta Stopped Momenta and Novartis receive a not-approvable letter for their new drug application on their generic version of Lovenox, due to worries that it might cause an immune reaction. Investors, take note. |
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 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 December 28, 2010 Brian Orelli |
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. |
The Motley Fool March 18, 2009 Brian Orelli |
Johnson & Johnson and Shakespeare The stage is set for a dramatic decision. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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 July 28, 2010 Brian Orelli |
Fighting Hard to Keep a Blockbuster Sanofi is suing the FDA to take back approval of a competing generic drug. Did you expect something different? |
The Motley Fool September 11, 2007 Brian Lawler |
Where Momenta Stands Momenta Pharmaceuticals updates investors as to the status of drugs in its pipeline. Until the FDA makes up its mind on its lead drug, an anticoagulant, it's anyone's guess as to what the value of the pipeline is. Investors should take note. |
The Motley Fool May 9, 2007 Brian Lawler |
Where Is Momenta's Momentum? Momenta awaits an FDA regulatory decision and announces quarterly financial results. Investors, take note. |
The Motley Fool May 26, 2009 Brian Orelli |
When Higher Costs Are a Good Thing The Food and Drug Administration proposed its budget for the next fiscal year, including user fees for pharmaceutical companies. But GlaxoSmithKline, Merck, and the rest of the industry probably won't complain too loudly. |
The Motley Fool November 2, 2010 Travis Hoium |
Momenta Pharmaceuticals Shares Plunged: What You Need to Know Momenta Pharmaceuticals shares fell 10% in trading early Tuesday after Teva Pharmaceutical Industries said it expects FDA approval this year on a drug to compete with Momenta's enoxaparin. |
The Motley Fool September 17, 2009 Brian Orelli |
Sleepless in Sanofi It's nothing but sleepless nights for sanofi-aventis, and there's no drug to cure it. |
The Motley Fool December 31, 2007 Brian Lawler |
Does Leadership Count at the FDA? Let's take a look at how drug approval rates have fared under different FDA commissioners. |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
The Motley Fool November 16, 2007 Brian Lawler |
Scrutinizing FDA Drug Approvals Comparing the FDA's approval rate of new drugs by calendar year illustrates that the pace of approvals certainly has slowed since the 2004 recall of Merck's anti-inflammatory compound Vioxx. |
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 April 7, 2011 Brian Orelli |
Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market. |
The Motley Fool March 3, 2009 Brian Orelli |
A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals. |
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 July 23, 2010 Luke Timmerman |
Momenta Gets FDA Green Light for Generic Anti-Clotting Drug The FDA says "yes" to Momenta Pharmaceuticals. |
The Motley Fool May 18, 2009 Brian Orelli |
Is There Life After 600% Returns? Just because a drug company gets a massive increase in the stock price after a positive clinical trial or an FDA approval, that doesn't mean all the growth is completely factored into the stock price. |
The Motley Fool May 10, 2006 Brian Lawler |
Dendreon Drives On Will the FDA say yes to a new cancer drug? Investors, take note. |
The Motley Fool December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
The Motley Fool March 3, 2009 Brian Orelli |
Stop Worrying About Follow-On Biologics They're inevitable, but they won't hurt biotech as much as you might think. |
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 February 4, 2009 Brian Orelli |
Not If, but When, for Lilly At least Lilly now knows that it's just a matter of time until the anti-clotting agent wins FDA approval. |
The Motley Fool January 17, 2007 Brian Lawler |
Dendreon in the Fast Lane The FDA speeds up review of Dendreon's leading drug candidate. Investors, take note. |
The Motley Fool November 10, 2006 Brian Lawler |
Dendreon Pending Approval A lot is riding on what the FDA will say about the small pharma's drug for prostate cancer. Investors, take note. |
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 August 28, 2007 Brian Orelli |
Teva Gets a Two-For Even for a maker of generic drugs, getting two FDA drug approvals in as many business days is a feat not often seen. Teva Pharmaceuticals managed to do it, though. Investors, take note. |
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 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 March 16, 2009 Brian Orelli |
Will the New FDA Chief Make Your Investments Healthy? President Obama's choice of Margaret Hamburg as head of the FDA seems to signify that the president is interested in the agency turning its focus toward protecting American's health. |
The Motley Fool January 16, 2008 Brian Orelli |
Headache Almost Over for Pozen The drug is safe; hopefully that's all the FDA wanted to know. |
The Motley Fool March 16, 2010 Brian Orelli |
How to Lose $114 Million in One Day You've got to be a very trusting investor to buy shares in pharmaceutical company, MannKind. |
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 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 26, 2010 Brian Orelli |
Black Friday Biotech Bargains Drugmakers on sale. |
The Motley Fool October 8, 2007 Brian Orelli |
Pozen Submits Safety Data Will Pozen's response to its second approvable letter be enough? Investors may want to take this with a grain of salt. |
The Motley Fool October 8, 2007 Brian Orelli |
New FDA Regulations for Drugmakers To deal with a growing backlog of pending applications, the FDA plans to stop its first-come, first-served system. |
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 February 10, 2009 Brian Orelli |
Roses and Candy From the FDA? Some drugmakers expect the FDA to bestow its kiss of approval this month. Read on to see who. |
The Motley Fool June 25, 2007 Brian Orelli |
Leading the Pack of Follow-On Drug Makers Generic drug maker Dr. Reddy's Laboratories is taking a huge risk to get ahead of the pack, but it's well worth the rewards of being in front of its competitors. Investors, take note. |
The Motley Fool April 24, 2008 Brian Lawler |
FDA Stings Genzyme Earnings A nasty surprise hurts the drug developer's first quarter results. |