Food And Drug Administration-Health Care Professional-Breast Cancer Treatment-Benzocaine Products

Teething Baby? Avoid Benzocaine, FDA Says

SUNDAY, July 29 (Healthday News) -- Parents should not use benzocaine products to relieve teething pain in babies except under the advice and supervision of a health care professional, the U.S. Food and Drug Administration says. read more..

source:http://yhoo.it/Q4CgXg

Novartis drug Afinitor gets EU nod for breast cancer

A man walks past the logo of Swiss drugmaker Novartis AG in front of a plant in Basel

ZURICH (Reuters) - Novartis drug Afinitor, expected to become a major seller for the Swiss drugmaker, was approved by European regulators to treat women with a certain type of breast cancer, the company said on Monday. The drug is the first in a class known as mTOR inhibitors to be approved for post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. American health regulators also backed the drug as a breast cancer treatment. ... read more..

source:http://yhoo.it/Q4CbCI

Food And Drug Administration-Health Professionals-Obesity Epidemic-Healthday News

2 New Weight-Loss Drugs Won't Reverse U.S. Obesity Crisis

THURSDAY, July 19 (Healthday News) -- The U.S. Food and Drug Administration's approval of two new weight-loss Drugs within the past month -- the first such medications in 13 years -- won't be a panacea for America's obesity epidemic, health professionals say. read more..

source:http://yhoo.it/MMaQ3N

Food And Drug Administration-Orasure Technologies Inc-HIV

FDA approves first at-home HIV test from OraSure

(Reuters) - U.S. health regulators on Tuesday said they approved OraSure Technologies Inc's in-home test for HIV, making it the first over-the-counter, self-administered test for the virus that causes AIDS. The Food And Drug Administration gave its green light to the OraQuick In-Home HIV Test, which within 20 to 40 minutes provides results from an oral fluid sample taken by swabbing the upper and lower gums inside the mouth. Shares of the company, which were halted pending the FDA announcement, closed up 5.2 percent at $12.10 on Nasdaq. ... read more..

source:http://yhoo.it/LR0DpJ

Food And Drug Administration-Blood Clot Preventer-Bristol-Myers Squibb-Health Regulators

Bristol/Pfizer clot preventer delayed in U.S

(Reuters) - A closely watched blood clot preventer from Bristol-Myers Squibb Co and Pfizer Inc has failed to win approval from U.S. health regulators, the companies said on Monday. Investors have been awaiting a decision on the drug, Eliquis, by the Food And Drug Administration by the end of the month. The FDA notification did not require the companies to complete any new studies, the companies said, which could mean only a short delay before the drug wins approval. Rather, the agency wants more information on data management and verification from a key clinical trial supporting the medicine. ... read more..

source:http://yhoo.it/MmEDll

The European Medicines Agency-Food And Drug Administration-Theratechnologies Inc

Theratechnologies sinks on HIV drug setback

(Reuters) - Theratechnologies Inc shares plummeted more than 60 percent on Friday after the Canadian drugmaker said its European partner, Ferrer Internacional SA, was withdrawing a marketing application for its lead drug for HIV patients. The Spanish company's decision to pull the European Medicines Agency application for tesamorelin, used to reduce excess abdominal fat in HIV-infected patients with lipodystrophy, was made after a health committee raised safety concerns. The injectible drug is already approved by the U.S. Food And Drug Administration, according to the company's website. ... read more..

source:http://yhoo.it/Lpt4Lm

Food And Drug Administration-Prescriptions-Antibiotics-The Drugs-ADHD

U.S. kids getting more ADHD drugs, fewer antibiotics

The headquarters of the U.S. Food and Drug Administration is shown near Washington

NEW YORK (Reuters Health) - The number of drugs dispensed to U.S. minors has dropped slightly over the past decade, bucking the rise in prescriptions to adults, according to a government report out Monday. Antibiotics use fell by 14 percent, suggesting efforts to curb rampant overuse of the drugs "may be working," researchers from the U.S. Food and Drug Administration (FDA) write in the journal Pediatrics. Experts say antibiotics are commonly used to treat infections caused by viruses, although they only work against bacteria. That has fueled the growth of drug-resistant superbugs. ... read more..

source:http://yhoo.it/M6CloM

First Artificial Heart Valve-Food And Drug Administration-Health Officials-Safety Questions

FDA reviews safety of innovative heart valve

FILE-This Tuesday, Sept. 21, 2010, file photo, shows a model of a minimally invasive heart valve by Edwards Lifesciences Corp. in Washington. The Food and Drug Administration said Monday, June 11, 2012, that the heart valve compared favorably to surgery after one year, with patients living about the same amount of time. However, reviewers said patients who got the Sapien valve had a higher rate of

Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, ahead of a meeting this week to consider broadening its use. read more..

source:http://yhoo.it/LG1IRH

Food And Drug Administration-Swiss Pharmaceutical Company-Blockbuster Cancer Drug

Roche's breast cancer drug gets FDA nod

Logo of Swiss pharmaceutical company Roche is pictured in Rotkreuz

(Reuters) - U.S. health regulators have approved a new breast cancer drug from Roche Holding AG that the company hopes will become the standard treatment for women with an aggressive, incurable form of cancer. Roche unit Genentech announced Friday that the Food and Drug Administration approved the injectable drug Perjeta for women with a type of breast cancer known as HER-2 positive, which makes up about a quarter of all breast cancers and has no cure. Analysts predict the medicine could be another blockbuster cancer drug for the Swiss company. ... read more..

source:http://yhoo.it/Ms612a

Food And Drug Administration-Drugmaker Novo Nordisk-Health Regulators-Insulin

Novo Nordisk hit by U.S. delay to new insulin drug

The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring near Washington

COPENHAGEN (Reuters) - Danish drugmaker Novo Nordisk, the world's biggest insulin maker, said on Friday that U.S. health regulators had extended their review of its new ultra-long-acting insulin Tresiba, or degludec, to consider further data. The unexpected delay is a disappointment since degludec is a pivotal new product with which Novo hopes to consolidate its position in the fast-growing diabetes market. Shares in the group fell 3.1 percent by 0740 GMT. ... read more..

source:http://yhoo.it/KNZYpR

Food And Drug Administration-Overuse Of Antibiotics-Federal Court-Court Filings

FDA urged to rethink on antibiotics in animal feed

(Reuters) - A federal judge asked the Food And Drug Administration (FDA) to reexamine its decision to reject citizen calls to restrict the use of antibiotics in animal feed, court filings showed. The latest ruling is the second such setback for the FDA over concerns that overuse of antibiotics in animal feed is endangering human health by creating antibiotic-resistant "superbugs". In March, a federal court ordered the FDA to begin proceedings to withdraw approval for the use of penicillin and tetracyclines in animal feed unless makers of the drugs can produce evidence that their use is safe. ... read more..

source:http://yhoo.it/L5qiJt

Food And Drug Administration-Gilead Sciences-Hiv Infection

FDA panel backs first pill to block HIV infection

The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS. read more..

source:http://yhoo.it/LvWxkA

FDA panel backs first pill to block HIV infection

The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS. read more..

source:http://yhoo.it/LvWxkA

Food And Drug Administration-Salix Pharmaceuticals Ltd-Health Regulators-Full Review

FDA extends review for Salix diarrhea drug

(Reuters) - Salix Pharmaceuticals Ltd said U.S. health regulators have extended the review date by three months for its experimental pill for HIV therapy-related diarrhea. The U.S. Food And Drug Administration was to review the drug, crofelemer, on June 5. The FDA has notified Salix that it requires additional time for a full review but did not seek any additional studies, the company said in a statement. Salix holds the North American and European rights to the drug. ... read more..

source:http://yhoo.it/Jz2Y78

Food And Drug Administration-Birth Control Pills-Health Regulators-Fatal Blood Clots

US adds more on clot risk to some birth control pills

WASHINGTON (Reuters) - U.S. health regulators are adding information to the labels on a popular class of Birth Control pills that includes Bayer AG's Yaz and Yasmin, to show they may raise the risk of blood clots. All common birth control pills increase a woman's chances of getting potentially fatal blood clots. But the U.S. Food And Drug Administration said on Tuesday that some studies showed the danger may be even higher for more recent pills that contain the compound drospirenone, a synthetic hormone. ... read more..

source:http://yhoo.it/IyGjE1

Food And Drug Administration-Caramel Coloring-Health Risks-Tooth Decay-Pepsi

Warning Label Threat for Coke and Pepsi is Ridiculous

COMMENTARY | There are several health risks associated with being a chronic drinker of soda -- mainly tooth decay and obesity risks. But cancer from the caramel coloring used in Coke and Pepsi? You'd have to drink 1,000 cans a day to be at risk, according to the Food And Drug Administration. read more..

source:http://yhoo.it/wIctUA

Food And Drug Administration-Cholesterol Lowering Drugs-Health Regulators-Heart Disease

FDA adds diabetes, memory loss warnings to statins

(Reuters) - U.S. health regulators will add warnings to the labels of widely used cholesterol lowering drugs, such as Lipitor, to indicate that they may raise levels of blood sugar and could cause memory loss. The Food And Drug Administration announced the changes to the safety information on the labels of Statins such as Pfizer Inc's Lipitor, AstraZeneca's Crestor and Merck & Co's Zocor. Statins have been shown to significantly reduce the risk of heart attack and Heart Disease, and the FDA said the new information should not scare people into stopping taking the drugs. ... read more..

source:http://yhoo.it/yrNTZL

Food And Drug Administration-Skincare Products-Skin Care

Is your skin care making you sick? Buyer beware:

Is your Skin Care making you sick? Buyer beware:
How To Tell If Your Skincare Products Are Dangerous - Prevention.com
http://ow.ly/9zIEd
If you’re not sure where your favorite anti-aging products came from, you might be putting your health at risk without realizing it, according to a new report from The Food And Drug Administration. read more..

source:http://on.fb.me/zhpBme

Food And Drug Administration-Dangerous Blood Clots-Birth Control Pills-Health Officials

FDA eyes stronger warning on popular birth control

WASHINGTON (Reuters) - Health Officials are weighing stricter labels on the widely used new generation of Birth Control pills, based on data showing they may put women at a higher risk of dangerous blood clots. U.S. Food And Drug Administration staff reviewed studies comparing an older generation of birth control with newer pills that contain the compound drospirenone, such as Bayer AG's popular Yaz and Yasmin. ... read more..

source:http://yhoo.it/roMM7D

Food And Drug Administration-Health Regulators-Neurogesx Inc-Pain

FDA declines to approve NeurogesX patch for HIV pain

(Reuters) - U.S. health regulators declined to approve NeurogesX Inc's patch derived from chili peppers to treat HIV-related Pain and sought new trial data, and the company said it will cut half its workforce to save costs. The U.S. Food And Drug Administration told NeurogesX that to gain approval for the treatment, Qutenza, the company would need to submit additional clinical data from at least one adequate and well-controlled trial. ... read more..

source:http://yhoo.it/AD59du

Human Immunodeficiency Virus-Food And Drug Administration-Aids Healthcare Foundation

HIV pill for prevention debated as FDA ruling nears

(Reuters) - An advocacy group concerned about costs and possible Health Problems related to a drug being considered to help stop the spread of HIV infection to healthy people has asked U.S. regulators to delay or deny its approval. Los Angeles-based AIDS Healthcare Foundation (AHF) has petitioned the Food And Drug Administration on the grounds that studies have shown that the pill, Truvada, made by Gilead Sciences, is only partially effective in preventing transmission. The drug is already approved to treat people infected with the human immunodeficiency virus that causes AIDS. ... read more..

source:http://yhoo.it/wNkd9B

Food And Drug Administration-Dangerous Blood Clots-Birth Control Pills-Generation

FDA adviser: revise popular birth control labels

ADELPHI, Maryland (Reuters) - Health advisers recommended a revision of labels for the widely used new generation of Birth Control pills, based on data showing they may put women at a higher risk of dangerous blood clots. Outside experts advising the Food And Drug Administration on Thursday voted 21-5 that current labels inadequate reflected the risks and benefits of a newer generation of pills that contain the compound drospirenone, including Bayer AG's popular Yaz and Yasmin. ... read more..

source:http://yhoo.it/uQev5J