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The Motley Fool October 24, 2007 Brian Lawler	Pharmasset on the Fast Track Hepatitis and HIV drug developer announced that its lead antihepatitis C compound has received fast-track status from the FDA. The decision is not fantastic news, but it could help. Investors, take note.
The Motley Fool March 28, 2007 Brian Lawler	Nuvelo Gets Fast One of Nuvelo's compounds gets fast track designation. Investors, take note.
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 March 21, 2011 Brian Orelli	Let's See Some Data, Curis Curis investors seem to have shrugged off the multiple unknowns and embraced the potential for the company's skin cancer drug.
The Motley Fool July 29, 2011 Brian Orelli	2 Biotechs, 1 Promising Cancer Drug Perifosine on the home stretch.
The Motley Fool November 27, 2006 Brian Lawler	Pharmaxis Gets Good News From the FDA Fast-track designation gives this pharmaceutical stock a bump.
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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool December 31, 2011 Brian Orelli	3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012.
The Motley Fool March 30, 2010 Brian Orelli	Invest in This Space at Your Own Risk Lung cancer is a tough foe for drugmakers.
The Motley Fool December 8, 2006 Brian Lawler	Medarex Takes the Fast Route Medarex's lead drug gets an important yet expected designation from the FDA. Making a pharmaceutical company investment-worthy requires success in the clinic and the laboratory, but it also mandates that companies handle their finances correctly.
The Motley Fool November 10, 2006 Brian Lawler	Dendreon Pending Approval A lot is riding on what the FDA will say about the small pharma's drug for prostate cancer. Investors, take note.
The Motley Fool May 16, 2007 Brian Lawler	GPC's Next Cancer Drug? GPC Biotech prepares for its future as it awaits an FDA decision on its lead drug. Investors, take note.
The Motley Fool September 26, 2006 Brian Lawler	Four-Bagger Biotech in One Day Acorda's shares zoomed up, but potential investors should be cautious.
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 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 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 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 December 23, 2011 Selena Maranjian	3 Biotech Stocks That Had a Bad 2011 It's a volatile business, and these biotechs got the short end of the stick.
The Motley Fool July 31, 2007 Brian Orelli	GPC Takes a Pit Stop The biotech company pulls its New Drug Application for Satraplatin. There is something twisted about having to wait to get a drug to market because it's performing better than expected. Investors, take note.
The Motley Fool August 27, 2010 Brian Orelli	Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen.
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 June 2, 2010 Brian Orelli	Little Surprise. Big Stock Move. Investors like Amgen's early approval;shares are up 9% today, well ahead of the overall market.
The Motley Fool July 27, 2010 Jim Mueller	3 Stocks to Play Biotech Here are three promising ideas for this exciting area.
The Motley Fool March 13, 2008 Brian Lawler	Dendreon Rolls the Dice The pharmaceutical amends a phase 3 study on its lead prostate cancer drug.
The Motley Fool May 10, 2006 Brian Lawler	Dendreon Drives On Will the FDA say yes to a new cancer drug? Investors, take note.
The Motley Fool April 5, 2010 Brian Orelli	1 Month to Go! Is Dendreon a Buy? Only if you understand the risks.
The Motley Fool September 30, 2008 Brian Lawler	No Approval for You ... Yet The FDA makes Eli Lilly wait for word on a lead drug.
The Motley Fool June 18, 2010 Brian Orelli	Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday.
The Motley Fool November 29, 2011 Brian Orelli	Winners and Losers of Roche's Avastin Woes What the FDA giveth, the FDA can taketh away.
The Motley Fool September 13, 2007 Brian Orelli	Alfacell's Awkward Wait Waiting for subjects to die is a somber part of the oncology clinical trial process. Alfacell is doing just that in its final phase three trial with its lead cancer drug candidate. Investors take note.
The Motley Fool July 8, 2008 Brian Lawler	Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards.
The Motley Fool January 18, 2012 Brian Orelli	2 High-Flying Biotechs Face a New Hurdle The next number-one concern for Aeterna Zentaris' and Keryx's investors should be whether the drug passes its clinical trial.
The Motley Fool March 28, 2011 Brian Orelli	Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news.
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 June 12, 2007 Brian Lawler	ImClone Tries To Improve Erbitux ImClone is running trials to see if the drug can be used in earlier stages of cancer. Investors shouldn't discount the importance of an approved drug's product label.
The Motley Fool March 1, 2007 Brian Lawler	Know Your Drug Stock ABCs: Part 2 Investing in the pharmaceutical and biotechnology industries can be difficult. Here are terms investors should know to better understand how the clinical trial process involved with bringing a drug to market works.
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 March 26, 2008 Brian Lawler	Celgene Brings in an Orphan The Food and Drug Administration grants a Celgene drug orphan designation. Amrubicin may have an easier time in development for use in a limited patient population.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
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 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 May 24, 2010 Brian Orelli	ASCO Abstracts -- Pops and Drops! Ever since The American Society of Clinical Oncology began posting abstracts on-line -- and before that when they were sent to attendees -- investors have clamored to get a glimpse at the data. Here's your glimpse.
The Motley Fool January 26, 2009 Brian Orelli	Which One of These Is Not Like the Other? Bristol-Myers and Eli Lilly run into some comparability issues.
The Motley Fool April 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
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 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 December 29, 2011 Brian Orelli	What to Look for From Keryx and Aeterna Zentaris in 2012 The future is uncertain for these pharmaceutical companies.
The Motley Fool June 15, 2011 Brian Orelli	Investors Need a Peephole Into FDA Offices Cell Therapeutics is gung ho about its resubmission, but investors only get one side of the story.
The Motley Fool October 6, 2011 Brian Orelli	Data Published; Back to Waiting Phase 2 data for Aeterna Zentaris and Keryx's perifosine was published, but it's the phase 3 that's important.