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The Motley Fool June 24, 2011 Brian Orelli |
Come on, Pfizer, Not Even a Little Hint? Remoxy is rejected, but why? |
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 September 6, 2007 Brian Lawler |
Encysive, Please Stop Its failure to acquiesce to the FDA's request means the competition is going forward as this drugmaker's product stays stagnant. 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 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 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. |
The Motley Fool August 4, 2005 Charly Travers |
This One's a Winner Encysive awaits FDA approval, and all signs are positive. Biotech investors, take note. |
The Motley Fool December 10, 2010 Brian Orelli |
Was This Drug Destined for Failure? Pfizer announces that it's pulling Thelin off the market, and withdrawing the marketing application with the Food and Drug Administration, because a new side effect was discovered. |
The Motley Fool December 11, 2006 Brian Lawler |
Another Go for Encysive Drug Trials Sometimes shares of small specialty-pharma stocks rise and fall much more than warranted on every piece of news, and this appears to have happened to Encysive Pharmaceuticals. |
The Motley Fool June 18, 2007 Brian Lawler |
The Third Time Isn't the Charm for Encysive The approvable letter for the pulmonary arterial hypertension treatment marks the third time Thelin has failed to get full approval from the FDA. Investors, take note. |
The Motley Fool April 26, 2011 Brian Orelli |
We Hate Your Drug. And That's a Good Thing. This one's a pain for the clinical trial participants. |
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 February 21, 2008 Brian Lawler |
Learn From the Decisive Encysive Deal Encysive finally finds a buyer; Pfizer announces it will acquire the drugmaker for $195 million in cash. |
The Motley Fool June 15, 2007 Brian Lawler |
Encysive's Date With Destiny Approaches A decision on the specialty drugmaker's lead drug is imminent. Betting against the FDA is generally not a good idea for investors. Here are statements from Encysive's past press releases about Thelin |
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 October 5, 2010 Brian Orelli |
You Should Have Seen this FDA Rejection Coming This hepatitis C treatment was marked for failure. |
BusinessWeek June 12, 2006 Catherine Arnst |
Going From The Lab To Limbo The FDA has been delaying decisions on applications, and drugmakers are fuming. |
The Motley Fool October 25, 2010 Brian Orelli |
Arena's Boring News The Food and Drug Administration turned down Arena Pharmaceuticals' obesity drug, lorcaserin. Tell us something we didn't know. |
The Motley Fool July 25, 2006 Brian Lawler |
Strike Two for Encysive The FDA still won't quite give Thelin a thumbs-up. For now, Encysive investors can only sit and wait. |
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 May 11, 2006 Brian Lawler |
Encysive Evasive About Thelin The pharmaceutical stays tight-lipped about FDA approval of its new drug. Investors should keep an eye on Encysive's cash-burn rate in the coming months. |
The Motley Fool December 11, 2008 Brian Orelli |
A Painful Letter from the FDA The FDA smacked down King Pharmaceuticals and Pain Therapeutics with a complete response letter for their application to market Remoxy, an abuse-resistant controlled-release form of oxycodone. |
The Motley Fool November 3, 2009 Brian Orelli |
A Little Distracted, Are You, Merck? The FDA rejects its latest application. |
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 August 7, 2007 Brian Lawler |
Encysive's Congested Sales Failure Encysive Pharmaceuticals releases quarterly results that reveal a company with problems. Its cost structure is way out of line for a drugmaker of its size and potential. |
The Motley Fool February 11, 2011 Brian Orelli |
Biotech Optimists Throw In the Towel As the chance of survival improves, the stock falls. Wait, what? |
The Motley Fool October 5, 2011 Brian Orelli |
1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response. |
The Motley Fool July 10, 2008 Brian Orelli |
The Death of the Approvable Letter The name's changing, but for investors, little else will. |
The Motley Fool November 29, 2010 Brian Orelli |
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain. |
The Motley Fool September 24, 2007 Brian Lawler |
Encysive Hears the Voice of Reason To please the FDA, Encysive Pharmaceuticals announces it is planning an additional phase 3 trial to try and bring its lead drug, Thelin, to market in the United States. |
The Motley Fool February 25, 2011 Brian Orelli |
When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections? |
BusinessWeek May 27, 2010 Michelle Cortez |
Karo Bio's Prescription: Cheaper Drug Approval A Swedish company seeks a lower-cost review for its cholesterol drug. |
The Motley Fool January 15, 2010 Brian Orelli |
Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all. |
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 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 5, 2007 Brian Lawler |
Encysive in a No-Win Situation Encysive Pharmaceuticals needs help to get its lead drug onto the U.S. market in time to turn its financials around. Investors, take note. |
The Motley Fool January 28, 2008 Brian Lawler |
Can Encysive Catch the Competition? After two years of spectacular mismanagement, will 2008 be the year that Encysive Pharmaceuticals is finally able to capitalize on its very marketable lead drug, Thelin? |
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 18, 2010 Brian Orelli |
No Pain Here as Jazz Shares Rocket Investors are all jazzed up about Jazz Pharmaceuticals |
The Motley Fool April 13, 2011 Brian Orelli |
Drug Duo Escapes Advisory Panel Unharmed Pfizer and Novartis are on their way to expanding their cancer drug indications. |
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 May 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored. |
The Motley Fool December 15, 2006 Brian Lawler |
Reformatting Encysive Yet another delay from the FDA leaves investors hanging. |
The Motley Fool October 11, 2010 Brian Orelli |
FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that. |
The Motley Fool December 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. |
The Motley Fool June 20, 2011 Brian Orelli |
Pfizer's Pain-Free FDA Approval. More to Come? Oxecta gains FDA approval. Remoxy is up next. |
The Motley Fool March 30, 2010 Brian Orelli |
FDA Lags, Investors Flee Cephalon gets no love from the FDA. The agency failed to expand Cephalon's Nuvigil for the treatment of jet lag. |
The Motley Fool December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
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 August 9, 2010 Brian Orelli |
Dendreon's in Trouble Provided you call a slap on the wrist from the FDA "trouble." |