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You are here: Home / Archives for FDA

Cardio Drug Novel Novartis Faced Rejection By FDA

May 16, 2014 Posted by Staff

A complete response letter has been issued by FDA in context with the biologics license application for RLX030, Novartis reported. The move is the latest blow to a treatment Novartis yearned would be a keystone of a cardiovascular franchise. Also known as serelaxin, the drug is similar to the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the … [Read more...]

Filed Under: Health Tagged With: Cardio, cardio drug, FDA, heart failure drug, Novartis, novel novartis, rejected fda, serelaxin

Aspirin Efficacy Test to Help Heart Disease Patients

May 10, 2014 Posted by Contributor

Taking Aspirin for preventing heart attack may not be a good idea always, suggest researchers. Recently, the U.S. Food and Drug Administration has also questioned the efficacy of aspirin in preventing first heart attack or stroke in people who have never had cardiovascular problems. The researchers have now developed a simple test that can measure plaque in arteries of heart of the patients and … [Read more...]

Filed Under: Health Tagged With: Aspirin Test, aspirin therapy, FDA, Heart attack, heart stroke, Test for Aspirin

Aspirin against Heart Attacks Claims Doubtful – FDA

May 6, 2014 Posted by Contributor

The U.S. Food and Drug Administration has questioned the efficacy of aspirin in preventing first heart attack or stroke in people who have never had cardiovascular problems. Last week, the FDA has turned down the plea of German drugmaker Bayer AG to change the labeling on packages in order to market aspirin's value in preventing heart attacks in people who have never had cardiovascular … [Read more...]

Filed Under: Health Tagged With: Aspirin, Aspirin use in heart patient, Bayer AG, FDA, Heart attack, stroke

J&J suspends worldwide sale of fibroid surgery device following FDA advisory

April 30, 2014 Posted by Contributor

  Drug maker Johnson & Johnson has called off the worldwide sale of its fibroid surgery device as threat looms larger over its potential to spread undetected cancer beyond the uterus. The development comes following a Food and Drug Administration (FDA) advisory on April 17 that asked the doctors from using laparoscopic power morcellators to remove fibroids amid risk of worsening an … [Read more...]

Filed Under: Health Tagged With: FDA, fibroid surgery, fibroid surgery device, J&J, Johnson & Johnson, power morcellators

FDA gives green signal to Novartis’s ‘Zykadia’ to treat lung cancer

April 30, 2014 Posted by Contributor

The U.S. Food and Drug Administration has give its green signal to Novartis's new therapy drug 'Zykadia'(ceritinib) to treat a certain type of late stag non-small cell lung cancer (NSCLC). The early approval comes as a surprise as FDA was expected to finish reviewing the drug application by August 24, 2014 and then pronounce its verdict. Zykadia is the fourth drug with breakthrough … [Read more...]

Filed Under: Health Tagged With: FDA, lung cancer, lung cancer therapy, lung cancer treatment, non-small cell lung cancer, Novartis, NSCLC, Zykadia

Pap smears HPV Screening Test Approved by FDA

April 26, 2014 Posted by Staff

The Food and Drug Administration (FDA) has given its green signal to Roche Molecular Systems’s alternative papilloma virus test to treat cervical cancer, in women aged 25 and older. The test, commonly known as the Cobas HPV test, is a DNA-based test for the virus that can cause cervical cancer. Such DNA-based tools are being used by the doctors as a follow-up to confirm Pap test results. But … [Read more...]

Filed Under: Health Tagged With: cervical cancer, Cobas HPV test, DNA-based test for cervical cancer, FDA, Food and Drug Administration, PAP test

Electric shock devices to be history soon as FDA mulls its permanent ban

April 25, 2014 Posted by Staff

The shock devices and treatments will be a history soon as the Food and Drugs Administration is mulling over permanently banning such electric-shock devices used as therapies to treat patients with developmental disabilities and mental problems. In its 126-page report this week, the federal body has declared that it is reviewing electrical stimulation devices and may permanently ban their use … [Read more...]

Filed Under: Health Tagged With: Electric shock device, FDA, Food and Drug Administration, shock therapy

FDA gives nod to controversial Cobas HPV test

April 25, 2014 Posted by Contributor

The Food and Drug Administration (FDA) has given its green signal to Roche Molecular Systems’s alternative papilloma virus test to treat cervical cancer. The test, commonly known as the Cobas HPV test, is a DNA-based test for the virus that can cause cervical cancer. The research and clinical trial for the newly FDA-approved Cobas HPV test was conducted in Pleasanton. After the FDA nod, the … [Read more...]

Filed Under: Health Tagged With: cervical cancer, Cobas HPV test, DNA-based test for cervical cancer, FDA, Food and Drug Administration

FDA moves a step ahead in regulating electronic cigarettes

April 24, 2014 Posted by Contributor

In a major development, the federal government has decided to regulate the use of electronic cigarettes among minors by banning them, besides making approval for new products and health warning labels mandatory. The Food and Drug Administration (FDA) has not immediately enforced the changes for the modern smoking devices but has initiated the first step towards taming the fast-growing … [Read more...]

Filed Under: Health Tagged With: e-cigs, Electronic Cigarettes, FDA, modern cigarettes

QRxPharma shares plunges as Moxduo faces FDA’s rejection

April 23, 2014 Posted by Contributor

In a major setback for drug maker QRxPharma Ltd. (QRX), its shares plunged the most in Sydney trading since its initial share sale in 2007 after the advisors of U.S. Food and Drug Administration advisers denied approving its painkiller that combines two opioids. The company’s shares fell 80 percent to A$0.14 at the close of trading in Sydney. This was QRxPharma’s largest drop since it began … [Read more...]

Filed Under: Health Tagged With: FDA, Moxduo, painkiller, QRxPharma, QRxPharma shares, QRxPharma stocks, QRxPharma’S painkiller, Sydney trading

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