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...]
Aspirin Efficacy Test to Help Heart Disease Patients
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...]
Aspirin against Heart Attacks Claims Doubtful – FDA
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...]
J&J suspends worldwide sale of fibroid surgery device following FDA advisory
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...]
FDA gives green signal to Novartis’s ‘Zykadia’ to treat lung cancer
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...]
Pap smears HPV Screening Test Approved by FDA
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...]
Electric shock devices to be history soon as FDA mulls its permanent ban
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...]
FDA gives nod to controversial Cobas HPV test
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...]
FDA moves a step ahead in regulating electronic cigarettes
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...]
QRxPharma shares plunges as Moxduo faces FDA’s rejection
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...]
