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The Motley Fool June 17, 2004 Seth Jayson |
P&G Patches Up Sex Life? Proctor & Gamble announced that a second phase 3 clinical trial had demonstrated the safety and efficacy of its testosterone patch, to be called Intrinsa, for treating sexual dysfunction in women. |
The Motley Fool February 14, 2011 Brian Orelli |
This Biotech Is Heating Up Biosante Pharmaceuticals was up more than 9% at one point today after the company said the independent Data Monitoring Committee believed Biosante's female sexual dysfunction drug, LibiGel, was safe enough to allow the trial to continue. |
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 September 10, 2008 Brian Lawler |
A Pfizer Drug With a Cloudy Future The company offers another drug with mixed odds to the FDA. |
The Motley Fool January 29, 2008 Brian Lawler |
BioSante's Gamble Against Generics BioSante releases more information on the pivotal studies for its lead drug. |
The Motley Fool January 28, 2005 Karl Thiel |
Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous. |
American Family Physician December 15, 2005 Janelle Guirguis-Blake |
Hormone Therapy for the Prevention of Chronic Conditions in Postmenopausal Women The case study and answers to the following questions on hormone therapy for the prevention of chronic conditions in postmenopausal women are based on the recommendations of the U.S. Preventive Services Task Force (USPSTF). |
The Motley Fool January 4, 2012 Brian Orelli |
This Biotech's Obese To-Do List Is Done Arena resubmits lorcaserin for FDA approval. |
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 January 31, 2007 Brian Lawler |
FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer. |
American Journal of Nursing June 2011 Karen Roush |
Menopausal Hormone Therapy: What We Know Now This article describes the findings and limitations of the major research thus far on hormone therapy. |
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. |
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 December 27, 2006 Brian Lawler |
Bradley's Mediocre Drug Approval With the FDA's approval of Bradley's Elestrin, shares were up over 10% upon approval last week. |
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 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 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 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. |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
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 July 14, 2010 Luke Timmerman |
Vivus Faces Turning Point Tomorrow Thursday's the big day. All eyes will be on Vivus and the FDA's decision on their new obesity drug |
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. |
American Family Physician May 1, 2006 Margo & Winn |
Testosterone Treatments: Why, When, and How? Testosterone treatment is controversial for men and even more so for women. Although long-term outcome data are not available, prescriptions for testosterone are becoming more common. |
Salon.com July 10, 2002 Trisha Posner |
Death by hormones It's been more than 50 years since studies first sounded the alarm about hormone replacement therapy. Women, silenced by shame, have been guinea pigs of the pharmaceutical industry for too long. |
The Motley Fool February 23, 2005 Stephen D. Simpson |
Take Two on COX-2 FDA panel recommendations breathe new life into Merck and Pfizer's COX-2 pain medications. Looking ahead, investors should give a good, long look to the drug sector. |
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. |
Pharmaceutical Executive April 1, 2007 McCook & Daniels |
Making the Switch More companies are using Rx-to-OTC switches to extend a brand's life cycle. Prilosec did it. Here, experts dish on how you can do it too. |
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. |
Nurse Practitioner July 2011 Kass-Wolff & Fisher |
Menopause and the Hormone Controversy: Clarification or Confusion? Hormone therapy in perimenopause and menopause remains a controversial and often confusing management strategy for healthcare providers. To assist in providing women quality healthcare, recently published new guidelines help provide direction for NPs. |
BusinessWeek March 7, 2005 John Carey |
Side Effects Of The Drug Scares New fears give rise to a more honest look at the risks for a pill-popping nation. |
The Motley Fool April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate. |
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. |
American Family Physician July 1, 2000 Nancy A. Phillips |
Female Sexual Dysfunction: Evaluation and Treatment Sexual dysfunction includes desire, arousal, orgasmic and sex pain disorders (dyspareunia and vaginismus). Primary care physicians must assume a proactive role in the diagnosis and treatment of these disorders... |
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. |
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. |
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." |
Pharmaceutical Executive April 1, 2006 Jill Wechsler |
Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf? |
Nurse Practitioner January 2009 Clair Kaplan |
Assessing & Managing Female Sexual Dysfunction NPs can be important first-line, healthcare providers for women with FSD. |
BusinessWeek December 13, 2004 John Carey |
How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs. |
Pharmaceutical Executive July 3, 2007 Louis A. Morris |
Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way. |
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. |
Chemistry World April 4, 2012 Rebecca Trager |
FDA backs use of BPA in food packaging The US Food and Drug Administration says there is insufficient scientific evidence to ban bisphenol A in food packaging. |
The Motley Fool August 12, 2011 David Williamson |
Does "FDA" Stand for "Faster Drug Approvals"? FDA approvals for 2011 just surpassed 2010. |
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. |
American Family Physician May 1, 2006 |
Testosterone Therapy: What You Should Know A patient guide: What is testosterone?... Is it safe to take testosterone?... Are there any side effects of taking testosterone?... How do I take testosterone?... |
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. |
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. |
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? |
Pharmaceutical Executive December 1, 2013 |
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler. |
Pharmaceutical Executive June 1, 2006 Jill Wechsler |
Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules. |