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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. mark for My Articles similar articles
The Motley Fool
March 23, 2010
Brian Orelli
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
The Motley Fool
December 28, 2010
Brian Orelli
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. mark for My Articles similar articles
The Motley Fool
March 18, 2009
Brian Orelli
Johnson & Johnson and Shakespeare The stage is set for a dramatic decision. mark for My Articles similar articles
The Motley Fool
April 11, 2008
Brian Lawler
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate. mark for My Articles similar articles
The Motley Fool
December 31, 2010
Brian Orelli
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 8, 2010
Brian Orelli
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
April 7, 2011
Brian Orelli
Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
May 10, 2006
Brian Lawler
Dendreon Drives On Will the FDA say yes to a new cancer drug? Investors, take note. mark for My Articles similar articles
The Motley Fool
December 31, 2009
Brian Orelli
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
March 27, 2008
Brian Lawler
A Drugmaker's Candid Thoughts on the FDA Cardiome updates investors on its top two drugs. mark for My Articles similar articles
The Motley Fool
November 26, 2010
Brian Orelli
Black Friday Biotech Bargains Drugmakers on sale. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
April 24, 2008
Brian Lawler
FDA Stings Genzyme Earnings A nasty surprise hurts the drug developer's first quarter results. mark for My Articles similar articles