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The Motley Fool May 5, 2008 Brian Orelli |
A Short Wait for Discovery Labs? The company gets a third letter about Surfaxin, but should be able to satisfy the FDA soon. |
The Motley Fool May 25, 2007 Brian Lawler |
BioMarin Waits for Another Drug BioMarin files a marketing application for its lead compound in development. Investors, take note. |
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 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, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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 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 May 2, 2011 Tim Beyers |
Spectrum Pharmaceuticals Shares Popped: What You Need to Know Shares of Spectrum Pharmaceuticals rose as much as 14% in intraday trading after the Food and Drug Administration approved Fusilev as a colon cancer treatment. |
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 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 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 March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
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 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 December 27, 2010 Brian Orelli |
FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered. |
The Motley Fool April 1, 2008 Brian Lawler |
BioMarin Drug Heads Overseas One of the pharmaceutical's enzyme replacement therapy drugs gets approved in Japan. |
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 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. |
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 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 November 26, 2010 Brian Orelli |
Black Friday Biotech Bargains Drugmakers on sale. |
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 March 23, 2010 Brian Orelli |
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma. |
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. |
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 April 28, 2011 Brian Orelli |
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval. |
The Motley Fool December 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. |
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 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 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 5, 2010 Brian Orelli |
You Should Have Seen this FDA Rejection Coming This hepatitis C treatment was marked for failure. |
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 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 December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
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 October 8, 2010 Luke Timmerman |
Onyx Delays Cancer Drug Application As FDA Asks for More Data Shares fell about 7% in after-hours trading Thursday evening. |
The Motley Fool April 1, 2004 Charly Travers |
Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration. |
The Motley Fool February 27, 2007 Brian Lawler |
FDA Keeps Novartis Waiting The pharmaceutical experiences a regulatory setback in the U.S. for one of its top drug candidates. Investors, take note. |
The Motley Fool March 30, 2011 Brian Orelli |
Throw the Book at This Guy Cheng Yi Liang, a chemist for the FDA, was charged by the Securities and Exchange Commission with insider trading, among other allegations. |
The Motley Fool June 2, 2010 Brian Orelli |
Little Surprise. Big Stock Move. Investors like Amgen's early approval;shares are up 9% today, well ahead of the overall market. |
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 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 September 2, 2010 Luke Timmerman |
Orexigen Nabs $1B Deal With Takeda to Market Obesity Drug, Shares Climb San Diego-based Orexigen Therapeutics has found a partner to help it compete in the growing market for drugs to combat obesity, Japan-based Takeda Pharmaceutical. |
The Motley Fool February 25, 2011 Brian Orelli |
When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections? |
The Motley Fool February 24, 2011 Brian D. Pacampara |
Salix Pharmaceuticals Shares Plunged: What You Need to Know Shares of Salix Pharmaceuticals plummeted more than 20% after the company said it expects the Food and Drug Administration to deny its bid to gain expanded approval for its gastrointestinal antibiotic Xifaxan. |
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 March 21, 2011 Brian Orelli |
Let's See Some Data, Curis Curis investors seem to have shrugged off the multiple unknowns and embraced the potential for the company's skin cancer drug. |
The Motley Fool November 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |
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. |