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The Motley Fool May 30, 2008 Brian Orelli |
No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil. |
The Motley Fool March 25, 2009 Brian Orelli |
Wyeth: Now Approved to Kill More Bugs! Wyeth's antibiotic gets approved for another indication. |
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 January 16, 2008 Brian Lawler |
Better Safe Than Sorry at Theravance Pharmaceutical company Theravance is raising cash in advance of an FDA hearing. 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 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 May 29, 2009 Brian Orelli |
Delayed, Reason Unknown As long as Bayer and Johnson & Johnson can answer the FDA's questions relatively quickly, it shouldn't affect the companies too much. |
The Motley Fool November 28, 2008 Brian Orelli |
The FDA's Killing Bug Killers Unfortunately for Johnson & Johnson and Swiss drugmaker Basilea Pharmaceutica, the FDA appears a little reluctant to take some of the data for the drugmakers' antibiotic ceftobiprole at face value. |
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 February 28, 2008 Brian Lawler |
FDA's Mixed Signals for Theravance The FDA gives Theravance frustrating double messages about a lead drug. |
The Motley Fool December 31, 2009 Brian Orelli |
The FDA (Still) Hates Antibiotic Makers Johnson & Johnson and Basilea are the agency's latest victims. |
The Motley Fool May 29, 2009 Brian Orelli |
The Clouds Are Parting The Food and Drug Administration has scheduled an advisory committee meeting for Aug. 4 to get input on whether the agency should approve generic versions of ViroPharma's antibiotic, Vancocin. |
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 26, 2008 Brian Orelli |
Baxter Ready to Sop Up Additional Revenue The health-care giant licenses a surgical sponge in clinical development. |
The Motley Fool April 4, 2011 Brian Orelli |
Anti-Infective, Very Effective The FDA seems to like Optimer's new antibiotic. |
The Motley Fool February 23, 2010 Brian Orelli |
The One That Didn't Get Away After some encouragement, the FDA approves Gilead's Cayston. |
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 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 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 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 |
Down! Up! Which Way Will Optimer Go Next? Long-term prospects look good. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool July 9, 2008 Brian Lawler |
ViroPharma Makes Its Case Rather than taking the more traditional route, ViroPharma has taken steps to try to make it significantly harder than normal for a generic-drug maker to attack its lead drug, Vancocin. |
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 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 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 March 5, 2008 Brian Orelli |
FDA (Indirectly) Thwacks Amylin The FDA's draft guidance puts a cloud of uncertainty over the makers of diabetes drugs. |
The Motley Fool December 11, 2007 Brian Lawler |
Oncology Duo Takes a Gamble With trials complete, Medarex and Bristol-Myers-Squibb plan to submit less-than-stellar data on their skin cancer drug to the FDA. |
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 May 16, 2007 Mike Havrilla |
Biotech Prospects for a Sizzling Summer Consider these biotech stocks to make your portfolio sizzle this summer. Advanced Life Sciences... Depomed... Theravance... etc. |
The Motley Fool June 4, 2007 Brian Orelli |
OXiGENE's Moving Ahead The drug maker reaches a deal with FDA on its lead compound. Investors, take note. |
The Motley Fool July 23, 2007 Brian Lawler |
GPC's Date With the FDA A document released by the FDA outlines its concerns with GPC's lead drug. Investors, take note. |
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 5, 2009 Brian Orelli |
The Cash Cow Is Out of Milk ViroPharma has milked its antibiotic Vancocin, which it bought from Eli Lilly in 2004, pretty well, but it looks like the cash cow is finally running dry. |
The Motley Fool March 3, 2009 Brian Orelli |
A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals. |
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 March 27, 2009 Brian Orelli |
Dyax: A Cinderella Story Ends in a Fall FDA asks Dyax for more information. |
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 July 16, 2009 Brian Orelli |
Keep Your Chin Up, J&J An FDA advisory committee smacked down its drug candidate. |
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 November 14, 2008 Brian Orelli |
Gravy or Turkey From the FDA? Johnson & Johnson, Genzyme, and AstraZeneca should be made aware of their FDA fate over the next few weeks. |
The Motley Fool March 13, 2009 Brian Orelli |
Will These Drugs Get Past the FDA? Let's take a look at which pharma companies are hoping to score with the FDA this month. |
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 February 22, 2010 Brian Orelli |
So Long, See You in Arbitration After another rejection, Johnson & Johnson and Basilea call it quits. |
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 14, 2008 Brian Lawler |
Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure. |
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, 2007 Brian Lawler |
The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency. |
The Motley Fool March 10, 2008 Brian Orelli |
A Drug to Wake Up Schering Bridion gets an FDA panel review. |