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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. |
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 November 19, 2010 Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. |
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. |
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 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. |
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. |
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. |
The Motley Fool January 4, 2012 Brian Orelli |
Mark Your Calendars, Biotech Investors Cell Therapeutics' advisory panel meet ought to be entertaining. |
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. |
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 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 September 21, 2011 |
One Hot Stock to Avoid Our investing community's latest prime pick to avoid: MELA Sciences. |
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. |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
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. |
The Motley Fool January 7, 2011 Brian Orelli |
Dendreon Heads Across the Pond A pathway to Provenge approval in the EU. |
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 January 31, 2011 Brian Orelli |
5 Drugmakers Headed Back to the Drawing Board Sometimes an FDA rejection is more of a to-do list. |
Chemistry World May 27, 2015 Phillip Broadwith |
Label laundry It's been an interesting month in the world of off-label pharmaceuticals. |
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. |
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 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. |
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 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. |
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. |
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 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. |
The Motley Fool June 22, 2007 Brian Lawler |
Novartis' Good Week The pharma receives a pair of positive regulatory decisions. Investors, take note. |
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. |
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. |
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. |
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. |
IndustryWeek October 19, 2011 |
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? |
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. |
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. |
The Motley Fool February 26, 2011 Brian Orelli |
FDA Applications and a Look Ahead It isn't pretty. |
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. |
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. |
The Motley Fool September 16, 2010 Brian Orelli |
Abbott's Product Line May Get Thinner Not that it needs the obesity drug. |
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? |
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. |
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. |
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. |
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. |
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. |
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? |
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. |
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. |
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. |