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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 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 18, 2006 Stephen D. Simpson |
Survival of the Forest New products and a favorable patent ruling give Forest Labs a boost. Investors, this stock remains one to watch.  |
The Motley Fool January 12, 2006 Stephen D. Simpson |
Forest Keeps Reloading An agreement with Mylan Labs gives Forest access to a drug that could be launched in 2006. Investors, take note.  |
The Motley Fool May 1, 2006 Stephen D. Simpson |
Short-Term Fears Chip Into Forest Investors may be getting a second chance at unconventional Forest Labs. With the stock having pulled back, it's now very close to a tantalizing price.  |
The Motley Fool February 22, 2011 Ryan McBride |
Forest Labs Snaps Up Clinical Data This deal is the latest proof that drug developers with FDA-approved treatments remain hot buyout targets in a pharma industry that is starved for new products to replace brand-name drugs.  |
The Motley Fool July 14, 2006 Stephen D. Simpson |
The Diverging Fortunes of Forest and Teva If a patent ruling holds up, Forest's prospects are much stronger. Unfortunately, the easy money has long since been made in Forest and today's announcement will almost certainly mean another big jump in the stock price.  |
The Motley Fool March 31, 2005 Stephen D. Simpson |
Another "No" for Lexapro This latest FDA setback shouldn't hurt Forest Labs much, and the shares look like a bargain.  |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.  |
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 April 1, 2004 Charly Travers |
Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration.  |
The Motley Fool January 25, 2011 Brian Orelli |
FDA Approved -- Now Will It Sell? There's still plenty of uncertainty in Clinical Data's shares.  |
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 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 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 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 May 15, 2008 Brian Orelli |
Wanted: FDA Approval -- Pronto Teva and Amphastar have the courts on their side, but the FDA still stands in the way of a generic-drug launch.  |
The Motley Fool February 11, 2011 Brian Orelli |
Biotech Optimists Throw In the Towel As the chance of survival improves, the stock falls. Wait, what?  |
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 August 28, 2007 Brian Orelli |
Teva Gets a Two-For Even for a maker of generic drugs, getting two FDA drug approvals in as many business days is a feat not often seen. Teva Pharmaceuticals managed to do it, though. Investors, take note.  |
The Motley Fool October 18, 2005 Stephen D. Simpson |
Forest Labs' Clear-Cut Woes Patent litigation, generic competition, and drug development troubles nibble away at this pharmaceutical. 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 July 18, 2011 Brian Orelli |
A $3.6 Billion Franchise at Stake Amgen and Teva settle their patent dispute, and Amgen investors have a little better idea of when the company's $3.6 billion Neupogen and Neulasta franchise might come under attack in the United States.  |
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 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 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 19, 2007 Brian Orelli |
New Beta Blocker on the Crowded Street Forest and Mylan receive FDA approval for Bystolic. Investors, take note.  |
The Motley Fool January 14, 2005 W.D. Crotty |
An FDA OK That Hurts EPIX Pharmaceuticals gets a qualified "yes" from the FDA, sending its stock tumbling.  |
The Motley Fool November 2, 2010 Travis Hoium |
Momenta Pharmaceuticals Shares Plunged: What You Need to Know Momenta Pharmaceuticals shares fell 10% in trading early Tuesday after Teva Pharmaceutical Industries said it expects FDA approval this year on a drug to compete with Momenta's enoxaparin.  |
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 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 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 18, 2009 Brian Orelli |
Is There Life After 600% Returns? Just because a drug company gets a massive increase in the stock price after a positive clinical trial or an FDA approval, that doesn't mean all the growth is completely factored into the stock price.  |
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 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 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 January 17, 2006 Stephen D. Simpson |
Forest Labs: Is Different Better? Forest isn't your typical pharmaceutical company, and that's both its boon and its bane for investors.  |
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 March 23, 2010 Brian Orelli |
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.  |
The Motley Fool October 22, 2009 Robert Steyer |
Nibbles Here and There at Forest Labs Forest Laboratories banks on its usual strategy of licensing and collaboration to offset generic-drug threats.  |
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 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 January 18, 2012 Sean Williams |
This Company is Quickly Approaching the Patent Cliff Earnings exceed expectations at drug manufacturer Forest Laboratories, but worries about future sales mount.  |
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 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 December 24, 2009 Brian Orelli |
Another Reason to Worry About Pfizer The FDA fails to approve Lyrica for treating anxiety.  |
The Motley Fool March 30, 2010 Brian Orelli |
FDA Lags, Investors Flee Cephalon gets no love from the FDA. The agency failed to expand Cephalon's Nuvigil for the treatment of jet lag.  |
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 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 November 8, 2006 Brian Lawler |
Stumbling Block for Adolor Another approvable letter from the FDA means investors may have to be patient.  |