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The Motley Fool April 5, 2010 Brian Orelli	Up 30%? What Are You People On? Fast-track designations aren't worth much more than the paper they're printed on.
The Motley Fool May 21, 2007 Brian Lawler	DUSA's Orphan Isn't Unique The pharmaceutical gets "orphan drug" status for its lead compound. 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 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 April 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
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, 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 February 26, 2011 Brian Orelli	FDA Applications and a Look Ahead It isn't pretty.
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 30, 2010 Brian Orelli	A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs.
The Motley Fool July 28, 2010 Jordan DiPietro	3 Biotechs on Your Radar Screen It's not easy keeping track of all the drugs coming in and out of the development pipeline, but if you can stay up to date, you often have an advantage
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 November 27, 2006 Brian Lawler	Pharmaxis Gets Good News From the FDA Fast-track designation gives this pharmaceutical stock a bump.
The Motley Fool May 2, 2011 Tim Beyers	Spectrum Pharmaceuticals Shares Popped: What You Need to Know Shares of Spectrum Pharmaceuticals rose as much as 14% in intraday trading after the Food and Drug Administration approved Fusilev as a colon cancer treatment.
The Motley Fool November 26, 2010 Brian Orelli	Black Friday Biotech Bargains Drugmakers on sale.
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 August 27, 2007 Brian Lawler	Round 2 for Genentech Learn a lesson or two from Genentech's's dance with the FDA. The drugmaker's experience serves as a reminder of the fickle nature of the government agency, and the sometimes frustrating process of bringing a medication to market.
The Motley Fool February 18, 2010 Brian Orelli	Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance.
The Motley Fool January 28, 2010 Brian Orelli	How to Make a Billion Bucks in Biotech Drug companies and investors alike have to balance the risk and reward.
The Motley Fool February 28, 2011 Brian Orelli	Rare Diseases, Big Opportunity "Orphan" drugs to keep your eye on.
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 July 12, 2010 Ryan McBride	Synta Pharma CEO Trumpets New Top Cancer Drug Synta Pharmaceuticals has been climbing back from one of the Boston area's highest-profile clinical trial failures of 2009.
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 July 16, 2007 Brian Lawler	Slight Setback for ImClone ImClone announces a failed cancer study. Investors, take note.
The Motley Fool May 26, 2011 Brian Orelli	Congress Sets Bad Precedent With AVANIR What happened to free markets?
Chemistry World June 22, 2011 Sarah Houlton	US Approves Cancer Drugs Twice as Fast as Europe Cancer drugs are, on average, approved nearly twice as fast in the US than they are in Europe.
The Motley Fool March 11, 2010 Jim Mueller	Is Medivation a Buy? What is the thinking with regards to Medivation today? It already got a big haircut last week. Is it worth investing in at these lower prices?
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 July 30, 2010 Brian Orelli	3 Development-Stage Drugmakers Worth Watching A basket of potential drugs in just one company.
The Motley Fool November 16, 2007 Brian Lawler	Scrutinizing FDA Drug Approvals Comparing the FDA's approval rate of new drugs by calendar year illustrates that the pace of approvals certainly has slowed since the 2004 recall of Merck's anti-inflammatory compound Vioxx.
BusinessWeek August 26, 2010 Tom Randall	Cocktails Are Next For Cancer-Drug Makers Taking a cue from the cocktails of drugs that have made AIDS survivable, drugmakers are pursuing combination therapies against cancer.
The Motley Fool May 28, 2010 Brian Orelli	This Drug Doesn't Work. But All Is Not Lost. Novartis cancer drug fails one trial, but there's still hope.
The Motley Fool May 31, 2011 Brian Orelli	Profit From This Growing Drug Trend Cancer drugs press on.
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 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.
BusinessWeek May 27, 2010 Michelle Cortez	Karo Bio's Prescription: Cheaper Drug Approval A Swedish company seeks a lower-cost review for its cholesterol drug.
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 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 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 May 31, 2011 David Williamson	Roundtable: The World's Best Biotechs Motley Fool analysts choose these as their favorite biotech stocks: Aeterna Zentaris... Seattle Genetics... BioMarin Pharmaceutical... Amarin...
The Motley Fool October 5, 2010 Brian Orelli	You Should Have Seen this FDA Rejection Coming This hepatitis C treatment was marked for failure.
The Motley Fool October 8, 2010 Luke Timmerman	Onyx Delays Cancer Drug Application As FDA Asks for More Data Shares fell about 7% in after-hours trading Thursday evening.
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.
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
The Motley Fool August 14, 2008 Brian Lawler	A Potentially Painless PDUFA Date King Pharmaceuticals and Pain Therapeutics get an appointment with the FDA.
Managed Care June 2002	Oncologists: FDA needs to speed up approval of cancer-fighting drugs A Competitive Enterprise Institute survey of cancer specialists found that almost 8 of 10 oncologists think the FDA's approval process has "hurt their ability, at least once in their medical careers, to treat patients with the best possible care."
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 September 9, 2010 Brian Orelli	Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September.
The Motley Fool December 8, 2010 Brian Orelli	Up 100% With Room to Fly Orexigen gets a positive FDA panel nod.