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Fast Company Pavithra Mohan |
Theranos Caves To Critics, Agrees To Release Data On Its Blood Tests CEO Elizabeth Holmes said the company will soon publish data that she claims will demonstrate the accuracy of Theranos blood tests. |
Fast Company Pavithra Mohan |
Blood Test Startup Theranos Calls WSJ Expose "Baseless" And "Erroneous" The WSJ's report essentially argues that the device developed by Theranos, called Edison, may not be operating as advertised. |
Fast Company Elizabeth Segran |
In A Second Punch, Theranos Defends Itself Against WSJ Expose CEO Elizabeth Holmes refuted the articles' claims that the company's blood-testing system was yielding inaccurate results and that it was using commercially available equipment, rather than proprietary technology. |
Fast Company Harry McCracken |
Theranos CEO Elizabeth Holmes Punches Back Against The Wall Street Journal The finger-stick blood-testing system maker was criticized in two WSJ articles. The company's CEO claims the articles are false. |
Fast Company Ungerleider &Tetzeli |
Theranos CEO Tried To Take Control From Stockholders In Late 2013 In the shareholder letter, Elizabeth Holmes asked investors to agree to a stock split and to the creation of two classes of common stock that would give her voting control over Theranos. |
Chemistry World May 14, 2009 Rebecca Trager |
Bloodshed for blood substitute makers The synthetic blood business has taken a hit as regulators pan products and two major players are brought to the brink of collapse. |
Pharmaceutical Executive September 1, 2010 |
The Testing of the Tests FDA seeks to regulate genetic tests more actively, while encouraging diagnostic development. |
Food Processing November 2007 David Joy |
Regulatory Issues: New rules on reporting contamination Manufacturers will not have the option of handing recalls quietly. Information may even appear on FDA's web site. |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
The Motley Fool July 12, 2011 Luke Timmerman |
Seattle Genetics' New "Empowered Antibody" Looks Clean in FDA Staff Documents FDA reviews Seattle Genetics' Hodgkin's lymphoma drug. |
The Motley Fool August 12, 2008 Brian Lawler |
The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers? |
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 January 14, 2005 W.D. Crotty |
An FDA OK That Hurts EPIX Pharmaceuticals gets a qualified "yes" from the FDA, sending its stock tumbling. |
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 April 26, 2011 Luke Timmerman |
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex? |
The Motley Fool May 15, 2008 Brian Orelli |
Wanted: FDA Approval -- Pronto Teva and Amphastar have the courts on their side, but the FDA still stands in the way of a generic-drug launch. |
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. |
Food Engineering February 11, 2009 |
FDA releases recall tool: Try it out! FDA's recall tool provides up-to-date info on Salmonella recalls |
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. |
The Motley Fool January 16, 2008 Brian Orelli |
Headache Almost Over for Pozen The drug is safe; hopefully that's all the FDA wanted to know. |
The Motley Fool March 17, 2008 Brian Lawler |
The Panelling on Amgen's Walls One FDA panel ruling is a win, another is much less upsetting than investors feared. |
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. |
American Family Physician December 1, 2000 William M. Rados |
Online Information for Health Care Professionals The home page of the U.S. Food and Drug Administration has undergone a major revision. The agency's Web site, which includes more than 100,000 documents, is now easier to search and covers the full scope of the FDA's activities... |
The Motley Fool April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate. |
Salon.com September 14, 2000 David Tuller |
Seeing red Gay men have long been infuriated by a government ban on their donating blood. This week the FDA is reconsidering its position. |
Pharmaceutical Executive February 1, 2012 Jennifer Ringler |
Industry Trees are Falling, But is FDA Around to Hear? Experts weigh in on FDA's long-awaited social media guidelines. |
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 April 29, 2008 Brian Orelli |
Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month. |
Pharmaceutical Executive January 1, 2009 Jill Wechsler |
FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order? |
The Motley Fool June 20, 2011 Brian Orelli |
See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely. |
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 26, 2008 Brian Orelli |
The FDA's Latest Victim Merck fails to get its Gardasil vaccine approved to treat older women. |
Pharmaceutical Executive September 1, 2008 Jill Wechsler |
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches. |
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. |
Reason July 2004 Caroline Waters |
Bloody Shame Unnecessary regulations are making American blood banks run dry. |
Bio-IT World April 15, 2003 Janet Woodcock |
FDA Director Explains the Changes The head of the Center for Drug Evaluation and Research discusses why the FDA is now kinder and gentler about Part 11 compliance. |
Pharmaceutical Executive August 1, 2014 Jill Wechsler |
Social Media Struggles Continue Tweeting limited, corrections okay, says FDA, as industry, regulators wrestle with the digital world. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
Food Engineering June 4, 2007 |
Congress to beef up inspection activities With one food recall after another making headlines, Congress appears intent on beefing up federal government food inspection activities. |
The Motley Fool September 4, 2008 Brian Lawler |
Sitting Tight in September This month, several drugmakers will hear about compounds awaiting approval, so we can expect some volatility in their share prices. Read on to see who's awaiting FDA news. |
The Motley Fool June 3, 2009 Brian Orelli |
No More Triple-Digit Returns? If FDA decisions could be predicted easily, investors might not get to enjoy triple-digit returns, so perhaps we shouldn't be too upset about the tight-lipped nature of the FDA. |
The Motley Fool October 19, 2010 Brian Orelli |
Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency. |
Food Engineering March 2, 2009 |
FDA Still Under Fire for Peanut Butter Crisis A key member of the US Senate is losing patience with the FDA over food safety issues. |
The Motley Fool June 29, 2004 Charly Travers |
Antegren Gets Priority Review The FDA steps up the drug's time line for approval. |
The Motley Fool March 31, 2008 Brian Lawler |
FDA Commish Joins Blogosphere Andrew von Eschenbach, the FDA's chief, starts a weekly blog. |
Chemistry World September 18, 2008 James Mitchell Crow |
Ranbaxy hit by US drug ban The US Food and Drug Administration (FDA) has banned the import of more than 30 drugs made by Ranbaxy, India's largest drugmaker. |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
Chemistry World July 2007 Victoria Gill |
Conflict of interest? The FDA has been questioned after a published study brought exposed cardiovascular risks associated with GlaxoSmithKline's diabetes drug, Avandia. |
IndustryWeek October 19, 2011 |
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? |