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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. |
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. |
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. |
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 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 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 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 December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
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. |
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 November 3, 2009 Brian Orelli |
A Little Distracted, Are You, Merck? The FDA rejects its latest application. |
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 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 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. |
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 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 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. |
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 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. |
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. |
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 December 28, 2010 Brian Orelli |
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. |
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 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. |
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. |
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 January 17, 2007 Brian Lawler |
Dendreon in the Fast Lane The FDA speeds up review of Dendreon's leading drug candidate. Investors, take note. |
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 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 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 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. |
The Motley Fool December 15, 2006 Brian Lawler |
Reformatting Encysive Yet another delay from the FDA leaves investors hanging. |
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 |
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. |
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 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. |
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. |
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 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. |
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? |
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. |
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. |
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. |
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? |
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. |
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? |
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. |
The Motley Fool October 11, 2010 Brian Orelli |
FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that. |
The Motley Fool March 27, 2008 Brian Lawler |
A Drugmaker's Candid Thoughts on the FDA Cardiome updates investors on its top two drugs. |
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. |