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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. 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
April 8, 2008
Brian Lawler
FDA Approvals ... Increase? So far in 2008, the agency has given more drugs a thumbs-up than this time in 2007. Take a look at which companies received approvals. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 5, 2007
Brian Lawler
The FDA Says It Needs a Pep Pill Drugmakers offering new treatments might be discouraged by the FDA's latest report, in which the agency makes its case for additional funding from Congress. mark for My Articles similar articles
The Motley Fool
February 26, 2011
Brian Orelli
FDA Applications and a Look Ahead It isn't pretty. mark for My Articles similar articles
The Motley Fool
March 16, 2009
Brian Orelli
Will the New FDA Chief Make Your Investments Healthy? President Obama's choice of Margaret Hamburg as head of the FDA seems to signify that the president is interested in the agency turning its focus toward protecting American's health. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2006
Kenneth I. Kaitin
Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do. 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
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. 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
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
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. mark for My Articles similar articles
The Motley Fool
April 11, 2008
Brian Lawler
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate. mark for My Articles similar articles
The Motley Fool
May 27, 2009
Brian Orelli
Meet the People Who'll Rule Your Investment Life If you're a drug company investor, that is. The new commissioner and principal deputy commissioner of the Food and Drug Administration introduced themselves and give investors a first look at how they plan to run the agency. mark for My Articles similar articles
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. 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
Pharmaceutical Executive
June 1, 2007
Patrick Clinton
From the Editor: Not His Problem In the current climate, who's going to get doctors to take on the work of making good decisions and occasionally the responsibility for having made a bad one? mark for My Articles similar articles
The Motley Fool
May 26, 2011
Brian Orelli
Congress Sets Bad Precedent With AVANIR What happened to free markets? mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2007
Patrick Clinton
From the Editor: Taking It Outside FDA Commissioner Andy von Eschenbach said something pretty reasonable, and in return received a blistering, menacing letter from Senator Charles Grassley -- a letter that showed yet again that Grassley just doesn't understand what he's destroying in his campaign against FDA. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2007
Clinton & Wechsler
The View From Inside Commissioner Andrew von Eschenbach on drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine. mark for My Articles similar articles
The Motley Fool
March 23, 2010
Brian Orelli
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma. mark for My Articles similar articles
CIO
March 15, 2006
Allan Holmes
Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2005
Jill Wechsler
Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency. 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
May 31, 2011
Brian Orelli
Pay Attention, Biotech Investors Competitors and partners can't be ignored. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2011
Jill Wechsler
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes mark for My Articles similar articles
The Motley Fool
July 29, 2010
Brian Orelli
Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
June 26, 2008
Brian Orelli
The FDA's Latest Victim Merck fails to get its Gardasil vaccine approved to treat older women. mark for My Articles similar articles
The Motley Fool
March 3, 2009
Brian Orelli
Stop Worrying About Follow-On Biologics They're inevitable, but they won't hurt biotech as much as you might think. mark for My Articles similar articles
The Motley Fool
June 26, 2008
Brian Lawler
Gauging Glaxo's Vaccine Value Surprise! The FDA actually approves Glaxo's new combination children's vaccine without delay. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2007
Jill Wechsler
Washington Report: Safety First FDA seeks to regain public trust by making drug-safety information more transparent - and to head off more stringent legislation in the process. mark for My Articles similar articles
The Motley Fool
April 7, 2011
Brian Orelli
Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market. mark for My Articles similar articles
The Motley Fool
October 18, 2006
Brian Lawler
Another Hard Pill to Swallow A former FDA chief will take the fall for not disclosing holdings, but the pharmaceuticals industry needs more than that. mark for My Articles similar articles
The Motley Fool
October 26, 2007
Brian Orelli
Investing in Follow-On Biologics Investors, while approvals of follow-on biologics in the U.S. are probably still years away, now is the time to do your research. Those that are leading the race overseas are likely to be first in line when the FDA opens its door to applications. mark for My Articles similar articles
The Motley Fool
June 29, 2010
Brian Orelli
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. mark for My Articles similar articles
The Motley Fool
March 31, 2008
Brian Lawler
FDA Commish Joins Blogosphere Andrew von Eschenbach, the FDA's chief, starts a weekly blog. 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
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. mark for My Articles similar articles
The Motley Fool
December 8, 2010
Brian Orelli
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. mark for My Articles similar articles
The Motley Fool
July 1, 2008
Brian Lawler
FDA News Gives Glaxo a Glimmer of Hope Approval is delayed, but new studies won't be needed for Cervarix. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
January 21, 2011
Brian Orelli
Mark Your Calendar, Drug Investors Vertex announces that the Food and Drug Administration has accepted its New Drug Application to market telaprevir. mark for My Articles similar articles
The Motley Fool
July 10, 2008
Brian Orelli
The Death of the Approvable Letter The name's changing, but for investors, little else will. mark for My Articles similar articles
The Motley Fool
August 12, 2011
David Williamson
Does "FDA" Stand for "Faster Drug Approvals"? FDA approvals for 2011 just surpassed 2010. mark for My Articles similar articles
The Motley Fool
December 31, 2009
Brian Orelli
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. mark for My Articles similar articles