Bonduelle USA announced on Monday that it is recalling more than 9,000 cases of frozen corn for fear of Listeria contamination.» Read More
Aug 20- Canada's Valeant Pharmaceuticals International Inc is nearing a deal to pay $1 billion for Sprout Pharmaceuticals, the company that just won approval to sell the first drug that aims to boost a woman's libido, the Wall Street Journal reported. The U.S. Food and Drug Administration late on Tuesday approved Sprout's drug for pre-menopausal women.
Aug 19- Medical device maker Boston Scientific Inc said the U.S. Food and Drug Administration approved its device to prevent the block of arteries in the legs which leads to peripheral artery disease.
Aug 19- AbbVie Inc has bought a priority review voucher from United Therapeutics Corp for $350 million that will allow it to accelerate the review process for one of its drugs. United Therapeutics received a rare pediatric disease priority review voucher in March after its drug, Unituxin, was approved by the U.S. Food and Drug Administration to treat...
The FDA approved the first prescription drug for enhancing female libido.
A so-called female Viagra may have received FDA approval, but the patients it may actually help could be limited, Dr. Lisa Dabney says.
The FDA has twice rejected the drug, flibanserin, made by privately held Sprout Pharmaceuticals. Shares of rival Palatin Technologies rose 29 percent to $1.21 in extended trade. Originally developed by Germany's Boehringer Ingelheim, flibanserin was first rejected by the FDA in 2010 after an advisory panel said the benefits did not outweigh the risks.
NEW YORK, Aug 18- A controversial drug to treat low sexual desire in women won approval from the U.S. Food and Drug Administration on Tuesday, but with a warning that about potentially dangerous side effects. The FDA has twice rejected the drug, flibanserin, made by privately held Sprout Pharmaceuticals. It has been nicknamed "female Viagra" in media reports, even...
The drug, Addyi, is the first approved by the FDA to treat sexual desire disorders in men or women.
Aug 18- Amgen Inc has reached a $71 million settlement with 48 U.S. states and the District of Columbia to resolve claims that the biotechnology company promoted its popular Enbrel and Aranesp drugs for uses not approved by the federal Food and Drug Administration. Authorities said Amgen violated state consumer protection laws by marketing both drugs for...
A decision is expected today from the FDA on Flibanserin, a pill to improve female libido.
Aug 17- The U.S. Food and Drug Administration said it has issued warning letters to manufacturers of medical scopes linked with recent superbug outbreaks, citing violations found during inspections of facilities in the United States and abroad. The devices, called duodenoscopes, are flexible tubes inserted down the throat in a procedure called endoscopic...
Aug 13- The U.S. Food and Drug Administration has approved the use of opioid painkiller OxyContin in patients aged 11 to 16 who have not benefited enough from alternatives. Accordingly, the FDA had asked Purdue Pharma LP, which makes OxyContin, to evaluate the use of the drug in children. The company said is in talks with the FDA regarding securing an additional 6...
Aug 13- The U.S. Food and Drug Administration has approved the use of opioid painkiller OxyContin in patients aged 11 to 16 who have not benefited enough from alternatives. The long-acting drug already treats adults suffering from around-the-clock pain, and has been reformulated over the years to combat rising prescription drug abuse in the United States.
FDA approves use of Purdue Pharma's OxyContin by kids as young as 11.
The agency approved the powerful painkiller OxyContin for a new use in children 11 to 16 who are suffering from severe, long-term pain.
FDA sends warning letter re: Kardashian Instagram post.
The FDA issued a warning letter to a pharmaceutical company after Kim Kardashian posted a promotional selfie with one of its drugs.
Aug 6- Medtronic Plc will recall 6,912 units of the loading system of a recently approved heart device after reports of the presence of particulates, the U.S. Food and Drug Administration said. Medtronic said it received 8 reports related to the issue out of 7,347 potentially affected units through July 6, but no reports of "adverse patient effects".
Estimates of annual spending on PCSK9 drugs are as high as $150 billion, but drugmakers expect much lower.
Jack Khattar, Supernus Pharmaceuticals CEO, discusses a promising new drug that treats impulsive aggression in adults with attention-deficit hyperactivity disorder.