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The Motley Fool September 9, 2011 Brian Orelli |
Firing Squad, It Was Not J&J and Bayer get through their advisory panel with minimal problems. |
The Motley Fool March 18, 2009 Brian Orelli |
Johnson & Johnson and Shakespeare The stage is set for a dramatic decision. |
The Motley Fool August 21, 2008 Brian Orelli |
Johnson & Johnson Gets Rejected The FDA rejects Johnson & Johnson's bid to expand the label of its antibiotic. |
The Motley Fool April 6, 2011 Brian Orelli |
$1 Billion in Drug Sales Bleeds Out Don't feel too bad for Bayer and J&J though. |
The Motley Fool March 19, 2009 Brian Orelli |
One Down, One to Go Sanofi-aventis slides past an FDA panel and hopes for more good news today |
The Motley Fool September 7, 2011 Brian Orelli |
J&J and Bayer Head in Front of the Firing Squad An expanded indication for Xarelto seems unlikely. |
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 August 24, 2009 Brian Orelli |
J&J Would Rather Not Say Drug delayed, reason unknown. Should shareholders be worried? It's hard to tell. |
The Motley Fool May 26, 2009 Brian Orelli |
Will the FDA Approve These Drugs? Plenty of Prescription Drug User Fee Act dates are right around the corner. Read on to see which pharma companies may be affected. |
The Motley Fool July 5, 2011 Brian Orelli |
Drug Approved, But No Fireworks Yet The second FDA approval for Bayer and Johnson & Johnson's Xarelto is more important. |
The Motley Fool July 29, 2010 Brian Orelli |
This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either. |
The Motley Fool October 19, 2010 Brian Orelli |
When the Status Quo Is a Big Win The lack of an FDA rejection will do just fine. Amgen and Johnson & Johnson seemed to get through the FDA advisory panel process without much problem yesterday. |
The Motley Fool December 31, 2008 Brian Orelli |
An Imminent Drug Approval? Really? Lilly may finally hear about prasugrel. |
The Motley Fool June 16, 2011 Brian Orelli |
No Poke in the Eye Here What's the biggest sign that the Food and Drug Administration is all set to approve Regeneron Pharmaceuticals' Eylea? The briefing documents for the advisory committee contained a proposed version of the label. |
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 December 19, 2008 Brian Orelli |
Eli Lilly's Good News Misses the Mark EU approval of its blood thinner is nice, but U.S. approval is what will really matter. |
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 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 May 13, 2011 Brian Orelli |
FDA Advisory Panel Positive! Shares Punished. Despite the positive recommendation, investors aren't convinced BioMimetic's Augment will be approved. |
The Motley Fool November 30, 2009 Brian Orelli |
The FDA Moves the Goalposts The FDA sends a complete response letter to Theravance about its antibiotic Vibativ, which it's trying to get approved for treating patients with nosocomial pneumonia. |
The Motley Fool May 25, 2011 Brian Orelli |
Optimer's Upcoming FDA Decision: Memorable or Memorial? We'll know on Memorial Day, plus or minus a few days. |
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 June 17, 2009 Brian Orelli |
Savient Saves and Moves Up The FDA advisory panel gives Savient's Krystexxa a passing grade. |
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 July 16, 2009 Brian Orelli |
Keep Your Chin Up, J&J An FDA advisory committee smacked down its drug candidate. |
The Motley Fool December 11, 2009 Brian Orelli |
Gilead Gets the Experts on Its Side An advisory committee says yes after the FDA said no. |
The Motley Fool August 1, 2007 Brian Lawler |
Elan Gets a Vote of Confidence Elan receives some good news from an FDA advisory panel in the form of a recommendation to expand the use of Tysabri to treat Crohn's disease. |
The Motley Fool February 11, 2009 Brian Orelli |
The FDA's Bipolar Decision Johnson & Johnson announces that the FDA has asked for more information before approving its application to market Risperdal Consta for frequently relapsing bipolar disorder. |
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 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 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 June 2, 2008 Brian Orelli |
The Anticoagulation Competition Bloodbath Bayer and Johnson & Johnson give Sanofi's Lovenox another beating. |
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. |
The Motley Fool March 19, 2007 Brian Lawler |
Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. 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 July 27, 2010 Brian Orelli |
Brilinta? I Think Not. AstraZeneca's new blood thinner is far from brilliant. |
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 November 19, 2010 Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. |
The Motley Fool January 22, 2008 Brian Lawler |
Adolor Under the FDA's Spotlight The FDA releases its documents on Adolor's lead drug, with surprising good news in advance of an advisory panel discussion. Investors, take note. |
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 December 10, 2007 Brian Lawler |
Will the FDA Clear Cardiome? The agency prepares to debate Cardiome's lead drug candidate, Vernakalant, a treatment for abnormal heart rhythms. Investors, take note. |
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. |
The Motley Fool August 18, 2010 Brian Orelli |
More Pain Ahead for Eli Lilly? An advisory panel meeting tomorrow could further the company's slide. |
The Motley Fool August 18, 2011 Brian Orelli |
Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works. |
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 April 4, 2011 Brian Orelli |
Anti-Infective, Very Effective The FDA seems to like Optimer's new antibiotic. |
The Motley Fool November 15, 2010 Brian Orelli |
A Mega-Blockbuster Showdown Boehringer Ingelheim's Pradaxa was recently approved to treat patients with an erratic heartbeat, and Bayer and Johnson & Johnson have a second compound, Xarelto, that isn't far behind. |
The Motley Fool September 8, 2011 Arlene Weintraub |
Bristol-Pfizer Team on Alert as FDA Reviews Stroke-Prevention Drug From Rivals J&J and Bayer Who will come out ahead? |
The Motley Fool September 4, 2008 Brian Lawler |
Sitting Tight in September This month, several drugmakers will hear about compounds awaiting approval, so we can expect some volatility in their share prices. Read on to see who's awaiting FDA news. |
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. |