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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 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 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 March 24, 2009 Brian Orelli |
Taking the F Out of FDA President Barack Obama's nomination for deputy commissioner of the Food and Drug Administration has gotten people talking about the possibility of splitting the food safety portion away from the drug portion of the agency. |
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 June 11, 2009 Brian Orelli |
Kids, Take Your Antipsychotics! Drugs to combat mental illness might gain FDA approval for children. |
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 January 21, 2011 Brian Orelli |
Mark Your Calendar, Drug Investors Vertex announces that the Food and Drug Administration has accepted its New Drug Application to market telaprevir. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored. |
The Motley Fool November 16, 2009 Brian Orelli |
Music to Health-Care Investors' Ears Are faster FDA review times coming? |
The Motley Fool May 27, 2010 Brian Orelli |
This Rabid Agency Could Permanently Damage Your Portfolio The FDA has gotten a little out of control. The wonkiness of the FDA's actions makes it hard for investors to figure out what the agency will do. |
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 February 22, 2011 Brian Orelli |
A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S. |
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 January 28, 2011 Brian Orelli |
Looking Ahead at Bristol-Myers Product approvals now will help with the upcoming patent cliff. |
The Motley Fool February 26, 2011 Brian Orelli |
FDA Applications and a Look Ahead It isn't pretty. |
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 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 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 May 27, 2009 Brian Orelli |
It's Approved! Now Back to Work Now that Bristol-Myers has received approval on its cancer drug Sprycel, it can get back to working on getting it out of its niche market and approved to treat other types of cancer. |
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 15, 2010 Brian Orelli |
Drug Approved. Now Let's Sell This Baby! With ink still wet on its FDA approval, Savient continues its plan to find a buyer. |
The Motley Fool October 20, 2010 Brian Orelli |
There Are No Safe Biotech Investments Amylin Pharmaceuticals and its partners, Eli Lilly and Alkermes, announced yesterday evening that the Food and Drug Administration had asked for more data before approving its once-weekly diabetes drug Bydureon. |
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 March 15, 2010 Brian Orelli |
FDA Says "No Way!" Market Says "Yeah, Baby!" You can have it both ways. The Food and Drug Administration's response wasn't exactly what investors in Amylin Pharmaceuticals, Eli Lilly, and Alkermes were looking for, but they'll take it. |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
The Motley Fool March 28, 2011 Brian Orelli |
Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news. |
The Motley Fool April 14, 2011 Brian Orelli |
One Step Closer to Revenue for Delcath But, between getting the Chemostat paid for in Europe and approved stateside, there's still plenty for Delcath to be worried about. |
The Motley Fool August 27, 2008 Brian Orelli |
Another FDA Setback for Johnson & Johnson The company has to wait for an approval of its extended-release schizophrenia drug. Investors, take note. |
The Motley Fool May 19, 2009 Brian Orelli |
Flip-Flopping: Not Just for Politicians Anymore The FDA's change is good for companies. |
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 December 24, 2009 Brian Orelli |
Another Reason to Worry About Pfizer The FDA fails to approve Lyrica for treating anxiety. |
The Motley Fool June 23, 2010 Brian Orelli |
Duo of Diabetes Drug Deals Make J&J Better Licensing deals add to Johnson & Johnson's diabetes franchise. |
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 June 11, 2010 Brian Orelli |
Double-Digit Pop Because the Drug Still Works? Developments at Mannkind's shareholder meeting send stock soaring. |
The Motley Fool March 23, 2011 Brian Orelli |
Eli Lilly: Great Plan, Poor Execution Eli Lilly shuns large mergers, but hasn't produced drugs on its own. |
The Motley Fool April 8, 2008 Brian Lawler |
FDA Approvals ... Increase? So far in 2008, the agency has given more drugs a thumbs-up than this time in 2007. Take a look at which companies received approvals. |
The Motley Fool November 27, 2009 Brian Orelli |
A Mostly Meaningless FDA Approval After an accelerated approval, the positive effects of a full approval are minimal for Johnson & Johnson's drug, Intelence. |
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 January 28, 2010 Brian Orelli |
How to Make a Billion Bucks in Biotech Drug companies and investors alike have to balance the risk and reward. |
The Motley Fool June 26, 2008 Brian Orelli |
The FDA's Latest Victim Merck fails to get its Gardasil vaccine approved to treat older women. |
The Motley Fool July 29, 2010 Brian Orelli |
Forget Respect -- Dendreon Needs Sales! Dendreon's Provenge was approved months ago, but the data from the clinical trial supporting the FDA's decision was finally published in the New England Journal of Medicine this week. |
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 January 26, 2010 Brian Orelli |
Is Victoza's Victory in Vain? Novo Nordisk finally gets the FDA to sign off on its once-daily diabetes drug. |
The Motley Fool March 3, 2011 Brian Orelli |
3 Cheers for an FDA Rejection German drugmaker Merck said that the Food and Drug Administration had turned down its multiple sclerosis drug cladribine. The pill would have competed with Novartis' Gilenya, which gained FDA approval last year. |
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 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. |