The purview of the approval given by U. S. Food and Drug Administration to Gardasil (human papillomavirus vaccine) has been broadened to also comprise of anal cancer and other similarly linked precancerous lesions, as reported by the agency said in a news release.
Human papillomavirus (HPV) is linked to approximately 90% of the estimated 5,300 cases of anal cancer tested in the US every year, according to the FDA, which cited figures from the records of the American Cancer Society. More number of women tested positive than that of men.
Following criticism from the Food and Drug Administration for a device used for skin cancer detection device from MELA Sciences Inc, a panel of Government health experts are said to have voted in favor of the device intently.
An agency spokesman said that the panel had voted 8-7 with one abstention since it had been made very clear that the overall gains of the Company's hand-held MelaFind device happened to outweigh its risks.
This new device is said to have been designed to assist dermatologists spot cancerous skin moles with the help of computer imaging technology.
In an attempt to avert fractures and other skeletal complications for the people suffering from advanced cancer which has spread to the bones, the U. S. Food and Drug Administration has finally approved Xgeva (denosumab).
Xgeva's manufacturer, Amgen Inc said that around 75% of the people suffering from advanced cancer of the prostate, lung or breast, have high chances of it spreading to their bones.
Furthermore there is a very high probability of it leading to complications such as debilitating pain, bone fractures and compression of the spinal cord.
A painkiller prospective of bearing risk of inflicting deadly heart problems has been called off from the market on Friday at the request of federal regulators.
After the calls from the Food and Drug Administration, Xanodyne Pharmaceuticals of Newport, the manufacturer of the drug Darvon consented to pull off the drug from the market. The FDA's calls also apply to the Companies, which make versions of the drug called propoxyphene.
GlaxoSmithKline's drug Benlysta has shown green signal by an advisory panel of the US Food and Drug Administration for its experimental use for the treatment of disease lupus in US.
It is for the first time in past 50 years that a medicine in the class of drugs for treating lupus has been approved. The ultimate decision on the commercialization of the drug from the FDA would come on December 9.
On grounds of criticism from general masses and the ban imposed on caffeinated energy drinks in many states, U. S. regulators are giving warning to the manufacturers of these high-drinks about the hazards they pose and violation of federal rules.
On Wednesday, the U. S. Food and Drug Administration issued warning to four firms, Phusion Projects LLC, United Brands Co, New Century Brewing Co and Charge Beverages alleging them of marketing seven drinks that are unsafe to drink as they contain blend of caffeine and alcohol.
An advisory panel of the US Food and Drug Administration has given its vote for an approval of the first drug that has particularly been designed to combat lupus. The endorsement provided by the panel was overwhelming, with a 13-2 decision in benefit of the drug being developed by Human Genome Sciences from Rockville.
The decision made by the advisory panel was reached after a whirlwind debate that lasted for a day, though at the end of it, the drug was deemed safe for consumption.
The US Food and Drug Administration, has issued warnings to people against consuming counterfeit medicines that have not been approved by the food and medicine regulator. The FDA has announced that medicines being sold in America, without its stamp of approval are counterfeit, as per the directives of the Special Law on counterfeit drugs, RA8203.
The U. S. Food and Drug Administration has shown a green signal to Egrifta (tesamorelin) for being used as a treatment to fat deposits, which is a consequence of lipodystrophy associated with HIV.
As told by the agency, lipodystrophy related with HIV is caused due to antiretroviral drugs used in the condition. It could lead to fat accumulation around the liver, stomach and other abdominal organs.
The drug is manufactured by Theratechnologies, a Canadian pharmaceutical company.
Cigarette packages in the US will soon change, and will host larger, more graphic images as part of their warning labels. The development has raised a din of discussion among Americans.
The Food and Drug Administration's (FDA) proposed labels may soon become more vivid warnings, but they are still far from reaching the heights of explicitness that other countries' cigarette packages boast. For their part, Americans seems to be more fascinated with the prospect of incorporating images of corpses and cancer patients on packages.
The Food and Drug Administration on Wednesday announced new measures that it would take to discourage people from smoking. After cigarette packs had started carrying warning signs, regarding the dangers of smoking, the Government has decided to start posting graphic images on the packs.
Anti-smoking groups and health authorities have welcomed the announcement made by the government regarding the decision. The new announcement would be a drastic measure in the fight against smoking by the authorities.
Over 400 patients undergoing CT scans of their heads have received overdoses of radiation. The Food and Drug Administration announced on Tuesday that these were due to operator error.
In a letter to the Medical Imaging and Technology Alliance, the FDA has called on the machines' manufacturers, including General Electric, to fix the problem. It has also recommended that they compile all dosing information in an easily accessible form for operators, and that a pop-up warning device is installed to warn operators before they administer dangerous overdoses.
Four Loko is an energy drink that has gained widespread publicity. The drink's claim to fame is not a testament to its advertisers' prowess, however, but rather to its notoriety as a health risk. The beverage is a mixture of alcohol, caffeine, taurine and guarana-a mixture so stimulating that it has come to be known as `blackout in a can'.