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The Motley Fool September 27, 2007 Brian Lawler |
A Step in a Winding Road for Vanda Vanda Pharmaceuticals has submitted a new drug application to the FDA for its lead drug, iloperidone, emphasizing a new approach to reduce safety issues. Investors, take note. |
The Motley Fool August 3, 2007 Brian Lawler |
Vanda Announces Some Late-Stage Maneuvers Vanda Pharmaceuticals gets ready for a busy remainder of 2007. Management awaits approval on three different compounds in the near future. Investors should be prepared for a potentially volatile road ahead. |
The Motley Fool November 12, 2007 Brian Lawler |
Vanda Gets Set for a Busy 2008 Although it has no marketed products, Vanda Pharmaceuticals third-quarter reports set the stage for an exciting 2008. Investors. take note. |
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 2, 2007 Brian Lawler |
Vanda Advancing The development-stage biotech releases first-quarter financial results. 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 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 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. |
Pharmaceutical Executive April 1, 2011 |
Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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 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 June 3, 2011 Brian Orelli |
FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully. |
The Motley Fool September 8, 2010 Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area. |
The Motley Fool January 25, 2010 Brian Orelli |
No Way to Hide This Drug Approval FDA trumps Acorda on its good news. The biotech announced Food and Drug Administration approval of Ampyra, its drug to help multiple sclerosis patients walk better after the markets closed on Friday. |
The Motley Fool April 26, 2011 Luke Timmerman |
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex? |
The Motley Fool December 7, 2006 Billy Fisher |
Breakout at Vanda Good news on the company's schizophrenia drug sends its shares skyrocketing. |
The Motley Fool August 23, 2010 Brian Orelli |
No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week. |
The Motley Fool August 9, 2010 Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area. |
Nursing June 2010 Daniel A. Hussar |
New drugs 2010, part 2 In this article, you'll learn about 14 recently marketed new drugs. |
The Motley Fool January 31, 2011 Brian Orelli |
5 Drugmakers Headed Back to the Drawing Board Sometimes an FDA rejection is more of a to-do list. |
The Motley Fool January 29, 2010 Brian Orelli |
How to Make Billions of Dollars Without Really Trying Lackluster Alzheimer's drugs have been doing it for years. |
The Motley Fool April 1, 2011 Travis Hoium |
Optimer Pharmaceuticals Shares Popped: What You Need to Know Shares of Optimer Pharmaceuticals jumped 12% today after positive news from the FDA was released. |
The Motley Fool August 18, 2010 Brian Orelli |
No Pain Here as Jazz Shares Rocket Investors are all jazzed up about Jazz Pharmaceuticals |
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 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 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
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 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 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 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
The Motley Fool February 29, 2008 Brian Lawler |
FDA Floors Eli Lilly Eli Lilly receives an especially harsh rebuke from the FDA about one of its top candidates when the agency refused to approve a long-lasting injection version of its multibillion-dollar Zyprexa for schizophrenia and bipolar disorder. |
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 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored. |
The Motley Fool December 12, 2006 Matt Koppenheffer |
The 5-Sigma Report A look at the stocks that saw serious volatility last week. Gallaher Group... Kyphon... Vanda Pharmaceuticals... Bank of New York... Pfizer... |
Nursing February 2010 Daniel A. Hussar |
New Drugs 2010, PART 1 In this article, you'll learn about 16 new drugs. |
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. |
Pharmaceutical Executive March 1, 2012 Ron Cohen |
FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership. |
Nursing June 2011 Daniel A. Hussar |
New Drugs 2011: Part 2 In this article, you'll learn about seven recently approved drugs, including: fingolimod hydrochloride, an oral drug indicated to treat patients with relapsing forms of multiple sclerosis. |
The Motley Fool September 30, 2010 Brian Orelli |
Avoid This Multibillion-Dollar Market It's just too crowded, but there's no doubt that psychiatric drugs are big business for some drugmakers. |
The Motley Fool March 25, 2011 Brian Orelli |
Pfile Pfizer Under "Potential" Researchers reported promising finding from a clinical trial of Pfizer's new drug, CP-870,893, in pancreatic cancer patients in the most recent issue of the journal Science. |
The Motley Fool May 19, 2009 Brian Orelli |
Flip-Flopping: Not Just for Politicians Anymore The FDA's change is good for companies. |
The Motley Fool February 26, 2011 Brian Orelli |
FDA Applications and a Look Ahead It isn't pretty. |
The Motley Fool June 27, 2008 Brian Lawler |
Vanda's Drug Draws a Yawn Shares of Vanda Pharmaceuticals have fallen more than 20% recently, even though the company said that its phase 3 clinical trial met its primary goal. |
Nursing March 2012 Daniel A. Hussar |
New Drugs 2012: part I In this article, you'll learn about 11 recently approved drugs. |
The Motley Fool March 31, 2011 Brian Orelli |
Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good. |
The Motley Fool December 27, 2010 Brian Orelli |
FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered. |
The Motley Fool July 21, 2011 Brian Orelli |
Keep an Eye on Biotech Partners' Earnings Novartis' earnings are important for small biotechs Momenta and Vanda. |
The Motley Fool February 18, 2010 Brian Orelli |
Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance. |