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The Motley Fool
December 29, 2006
Brian Lawler
Adams Tries to Fix Another Cough Adams Respiratory Therapeutics announced a new drug application filed. Investors, take note. mark for My Articles similar articles
The Motley Fool
December 11, 2007
Brian Orelli
Mucous Migrates East U.K.-based Reckitt Benckiser purchases Adams Respiratory Therapeutics, makers of Mucinex, for $2.3 billion. mark for My Articles similar articles
The Motley Fool
August 25, 2006
Ralph Casale
Adams Coughs Up Some Profits Adams Respiratory Therapeutics isn't suffering any off-seasonal ills. Investors, take note. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
The Motley Fool
December 22, 2003
Alyce Lomax
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. mark for My Articles similar articles
The Motley Fool
February 28, 2007
Brian Lawler
Discovery Prepares for Its Fate Discovery Labs announces its quarterly financial results as it prepares for another meeting with the FDA. Investors, take note. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
November 3, 2009
Brian Orelli
A Little Distracted, Are You, Merck? The FDA rejects its latest application. mark for My Articles similar articles
The Motley Fool
December 3, 2007
Brian Orelli
Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol. mark for My Articles similar articles
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 mark for My Articles similar articles
The Motley Fool
May 26, 2009
Brian Orelli
When Higher Costs Are a Good Thing The Food and Drug Administration proposed its budget for the next fiscal year, including user fees for pharmaceutical companies. But GlaxoSmithKline, Merck, and the rest of the industry probably won't complain too loudly. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
November 14, 2007
Brian Lawler
Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years. mark for My Articles similar articles
The Motley Fool
May 30, 2008
Brian Orelli
No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
October 8, 2007
Brian Orelli
New FDA Regulations for Drugmakers To deal with a growing backlog of pending applications, the FDA plans to stop its first-come, first-served system. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 28, 2010
Brian Orelli
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. mark for My Articles similar articles
The Motley Fool
December 31, 2010
Brian Orelli
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. mark for My Articles similar articles
The Motley Fool
September 24, 2008
Brian Orelli
Hey, You! Stop! The FDA has ordered Baxter and Hospira to stop making their ophthalmic balanced salt solutions within 60 days. mark for My Articles similar articles
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. mark for My Articles similar articles
BusinessWeek
June 12, 2006
Catherine Arnst
Going From The Lab To Limbo The FDA has been delaying decisions on applications, and drugmakers are fuming. mark for My Articles similar articles
The Motley Fool
January 17, 2007
Brian Lawler
Dendreon in the Fast Lane The FDA speeds up review of Dendreon's leading drug candidate. Investors, take note. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 15, 2006
Brian Lawler
Reformatting Encysive Yet another delay from the FDA leaves investors hanging. mark for My Articles similar articles
Chemistry World
November 21, 2014
Rebecca Trager
Ranbaxy sues over withdrawn US approvals Ranbaxy -- India's largest generics manufacturer -- has sued the US Food and Drug Administration after the agency withdrew tentative approval for the company to sell generic versions of two blockbuster drugs mark for My Articles similar articles
Chemistry World
February 14, 2012
Rebecca Trager
FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
May 19, 2006
Jim Mueller
Foolish Forecast: Mentor's Uncertain Results Factors outside of the cosmetic surgery products maker's control are leading to short-term uncertainty. Investors, take note. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2012
Jennifer Ringler
Industry Trees are Falling, But is FDA Around to Hear? Experts weigh in on FDA's long-awaited social media guidelines. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
November 8, 2007
Charly Travers
BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent. mark for My Articles similar articles
The Motley Fool
February 23, 2011
Cindy Johnson
Fear of the Future Outweighs HP's Great Quarter Did this tech titan's stock deserve to get slammed? mark for My Articles similar articles
Chemistry World
June 10, 2013
Phillip Broadwith
Sandoz manufacturing woes continue Sandoz, the generic drugs arm of Swiss firm Novartis, has had an official warning from the US Food and Drug Administration over failings at one of its manufacturing plants. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2013
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler. mark for My Articles similar articles
The Motley Fool
June 16, 2011
Brian Orelli
Are Two FDA Approvals in One Week a Positive Sign? Bristol-Myers Squibb received Food and Drug Administration approval for its kidney transplant drug Nulojix yesterday, marking the second approval this week from the FDA. mark for My Articles similar articles
The Motley Fool
October 30, 2007
Charly Travers
Winners and Losers in Big Pharma Some drugmakers are hitting a slump, but not all of them. Which ones can still cure what ails your portfolio? mark for My Articles similar articles
The Motley Fool
December 9, 2008
Brian Orelli
The FDA Can't See the Forest or the Trees Forest Laboratories and Cypress Bioscience are still waiting for FDA approval, but now they've got more data to prove their point. mark for My Articles similar articles
The Motley Fool
December 31, 2011
David Williamson
2011 Review: Cell Therapeutics After starting the year at a split-adjusted $2.22 a share, Cell Therapeutics stock lost almost 50% of its value by the end of December, closing at $1.16. How did we get here? mark for My Articles similar articles
The Motley Fool
June 3, 2011
Luke Timmerman
Orexigen, Facing High Hurdle at FDA, Puts Obesity Drug Development on Hold The close attention paid to safety makes this drug difficult to get right. mark for My Articles similar articles
The Motley Fool
October 11, 2010
Brian Orelli
FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that. mark for My Articles similar articles
The Motley Fool
March 27, 2008
Brian Lawler
A Drugmaker's Candid Thoughts on the FDA Cardiome updates investors on its top two drugs. mark for My Articles similar articles
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. mark for My Articles similar articles