Similar Articles

Browse Main Topics:

Business
Computers & Electronics
Education & Reference
Entertainment & Leisure
Family & Home
Finance & Investment
Health
Internet
Pets & Animals
Science & Technology
Society, Politics & Culture
Sports & Recreation

Similar Articles

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 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 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 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 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 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 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 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 11, 2009 Brian Orelli	Gilead Gets the Experts on Its Side An advisory committee says yes after the FDA said no.
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 December 31, 2009 Brian Orelli	The FDA (Still) Hates Antibiotic Makers Johnson & Johnson and Basilea are the agency's latest victims.
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 December 3, 2007 Brian Orelli	Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol.
The Motley Fool May 9, 2007 Brian Lawler	Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note.
The Motley Fool April 17, 2007 Brian Lawler	Neurochem Must Wait The FDA delays a regulatory decision on Neurochem's lead compound. Investors, take note.
The Motley Fool November 8, 2006 Brian Lawler	Stumbling Block for Adolor Another approvable letter from the FDA means investors may have to be patient.
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 August 31, 2009 Brian Orelli	Good Luck, Genzyme -- You'll Need It The drugmaker faces an FDA advisory-panel showdown regarding its leukemia drug Clolar.
The Motley Fool July 18, 2007 Brian Lawler	More Misery for Neurochem It's hard to find another drug developer that has mishandled its correspondence with investors about its drug candidates as badly as Neurochem has over the past year.
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 September 24, 2009 Brian Orelli	Wyeth's Biting the Hand That Feeds It Wyeth decides to sue the Food and Drug Administration after it approved Orchid Chemicals & Pharmaceuticals' generic version of its antibiotic Zosyn.
The Motley Fool December 10, 2007 Brian Lawler	Neurochem's Sure Bet at Failure Investors should add another regulatory date to their biotech calendars, this one regarding Neurochem's lead drug, KIACTA.
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 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 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 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 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 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 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 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 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 October 8, 2007 Brian Orelli	Pozen Submits Safety Data Will Pozen's response to its second approvable letter be enough? Investors may want to take this with a grain of salt.
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 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 August 3, 2007 Brian Orelli	Another Headache for Pozen Investors Drugmaker Pozen might have to run one more trial for the FDA for its migraine drug.
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 June 2, 2004 W.D. Crotty	FDA's Kiss of Life The FDA ignores its advisory committee and approves Allos' new drug.
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 June 12, 2007 Brian Lawler	Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg.
The Motley Fool December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
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 January 16, 2008 Brian Orelli	Headache Almost Over for Pozen The drug is safe; hopefully that's all the FDA wanted to know.
The Motley Fool October 8, 2007 Billy Fisher	Wheeling and Dealing at Wyeth A busy day at Wyeth. The company plans to submit a New Drug Application to the FDA, and acquires biopharmaceutical firm Haptogen.
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 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 August 12, 2008 Brian Lawler	The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers?
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 December 4, 2007 Brian Lawler	Will Avastin Squeeze Past the FDA? Unless an FDA advisory panel provides extremely strong reasoning for approving Avastin on the evidence of PFS benefits alone, Genentech and its investors should expect another approvable letter come January.