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The Motley Fool
September 26, 2011
Brian Orelli
Closer to Approval, Now Can MELA Find Customers? The restrictions might be too much. The company has been fighting for years to gain Food and Drug Administration approval of its melanoma detection device, MelaFind. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
November 19, 2010
Brian Orelli
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. mark for My Articles similar articles
The Motley Fool
November 3, 2011
Brian Orelli
FDA Approves! Investors Shrug. Investors just aren't that into MELA Sciences' newly approved melanoma detection device. 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
April 14, 2011
Brian Orelli
One Step Closer to Revenue for Delcath But, between getting the Chemostat paid for in Europe and approved stateside, there's still plenty for Delcath to be worried about. mark for My Articles similar articles
The Motley Fool
June 27, 2007
Brian Lawler
Waiting on GPC Exciting development-stage drugmaker GPC's marketing partner files a European marketing application for its top drug. mark for My Articles similar articles
The Motley Fool
May 13, 2011
Brian Orelli
FDA Advisory Panel Positive! Shares Punished. Despite the positive recommendation, investors aren't convinced BioMimetic's Augment will be approved. mark for My Articles similar articles
The Motley Fool
January 4, 2012
Brian Orelli
Mark Your Calendars, Biotech Investors Cell Therapeutics' advisory panel meet ought to be entertaining. mark for My Articles similar articles
The Motley Fool
October 26, 2009
Dave Mock
A Big Upgrade for Electro-Optical Sciences This bullish call comes from more than just one analyst. The Food and Drug Administration has put Electro-Optical Sciences' melanoma detection device on the fast track. mark for My Articles similar articles
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. 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
September 21, 2011
One Hot Stock to Avoid Our investing community's latest prime pick to avoid: MELA Sciences. mark for My Articles similar articles
The Motley Fool
December 31, 2007
Brian Orelli
Boston Scientific Restarts Its Heart Boston Scientific receives European approval for its defibrillator, giving the company a revenue boost even if the U.S. approval is delayed. mark for My Articles similar articles
The Motley Fool
December 22, 2003
Alyce Lomax
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. 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
The Motley Fool
January 7, 2011
Brian Orelli
Dendreon Heads Across the Pond A pathway to Provenge approval in the EU. 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
January 31, 2011
Brian Orelli
5 Drugmakers Headed Back to the Drawing Board Sometimes an FDA rejection is more of a to-do list. mark for My Articles similar articles
Chemistry World
May 27, 2015
Phillip Broadwith
Label laundry It's been an interesting month in the world of off-label pharmaceuticals. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2012
Ron Cohen
FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 7, 2006
Brian Lawler
The Best Small Cap for 2007: Encysive Pharmaceuticals This little drug maker has the potential for big profit, in both the U.S. and Europe. Investors, take note. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
January 28, 2011
Brian Orelli
Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result. 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
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." 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
June 22, 2007
Brian Lawler
Novartis' Good Week The pharma receives a pair of positive regulatory decisions. Investors, take note. mark for My Articles similar articles
The Motley Fool
February 4, 2009
Brian Orelli
Not If, but When, for Lilly At least Lilly now knows that it's just a matter of time until the anti-clotting agent wins FDA approval. mark for My Articles similar articles
The Motley Fool
February 27, 2009
Brian Orelli
Hooray for Stalemates! Government deadlock will likely bring more genetically engineered seeds to the EU, and good news for Syngenta, DuPont, and Dow Chemical. 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
InternetNews
March 6, 2008
EU Set to Clear Google-DoubleClick Merger: Sources Google is expected to receive unconditional approval from European Union regulators next week for its $3.1 billion takeover of ad firm DoubleClick. mark for My Articles similar articles
IndustryWeek
October 19, 2011
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? 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
Information Today
September 13, 2012
Joanna Ptolomey
Regulatory Compliance Shifts the mHealth Applications Market The market for medical apps that go through FDA clearance is currently small, but is expected to dramatically increase. The FDA is expected to issue detailed guidelines about mobile health devices and apps and their regulation in late 2012. 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
Food Processing
April 2006
David Joy
Regulatory Issues: WTO Sides With U.S. on GM Crops What the World Trade Organization decided on biotech foods in the European Union, and what it means to American producers. 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
September 16, 2010
Brian Orelli
Abbott's Product Line May Get Thinner Not that it needs the obesity drug. mark for My Articles similar articles
InternetNews
October 12, 2005
Colin C. Haley
A Real Settlement With Ripple Effects? Now that RealNetworks is willing to forgive and forget with Microsoft, will overseas regulators? mark for My Articles similar articles
Fast Company
David Lumb
Continuing Its Battle With Silicon Valley, The EU Will Probe How Ads Affect Search Results The EU commission is launching a separate investigation into how online platforms list search results and how they use customer data -- all as part of a general plan for a "unified digital market" announced last week. mark for My Articles similar articles
The Motley Fool
October 10, 2005
Stephen D. Simpson
The FDA: Boon, Bane, Whipping Boy Everyone wants the FDA to be faster, better, and cheaper, but that may not be a credible expectation. Investors would do well to keep an eye on the FDA because its policies and pressures ultimately filter down to our medicine cabinets, wallets, and portfolios. mark for My Articles similar articles
InternetNews
March 22, 2006
Roy Mark
Lukewarm Response to Microsoft's Latest EU Offer Microsoft's offer of "free, unlimited" technical support to rivals is generating only a lukewarm response from European Commission antitrust regulators. 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
InternetNews
March 31, 2006
Ed Sutherland
U.S. Backs Microsoft in EU Dispute By the end of the second day of Microsoft's hearings before the European Commission, there was an air of finality. mark for My Articles similar articles
InternetNews
November 13, 2009
Should Oracle Dump Europe Before MySQL? How far can Oracle afford to go if it can't win over European regulators to complete its purchase of Sun? mark for My Articles similar articles
Chemistry World
December 10, 2012
Andrew Turley
EU companies increasing R&D Companies in the EU are increasing their investment in R&D, despite the difficult economic conditions, according to a report from the European Commission that looked at the global top 1500 R&D investors. mark for My Articles similar articles
InternetNews
December 4, 2009
Microsoft and Yahoo Sign on the Dotted Line Microsoft and Yahoo quietly announced Friday that they have finally signed off on their landmark search in exchange for ad revenues deal. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2012
Jill Wechsler
Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market. mark for My Articles similar articles