The Food and Drug Administration is phasing out the use of antibiotics in meat over concerns about antibiotic-resistant bacteria.» Read More
In guidance issued on Wednesday, the FDA asked pharmaceutical companies to voluntarily revise labels of medically important antibiotics to remove references to use in animal production.
Dec 11- The U.S. Food and Drug Administration said it planned to phase out the use of some antibiotics in animals used for food, to prevent bacteria from becoming resistant to drugs used to treat humans.
Dec 9- An advisory panel of medical experts on Monday voted to recommend that U.S. health regulators approve an experimental drug for ulcerative colitis and Crohn's disease developed by Takeda Pharmaceutical Co..
WASHINGTON-- Shares of Acura Pharmaceuticals Inc. rose Monday after the company said it met with federal regulators to discuss a new version of the painkiller hydrocodone that uses the company's abuse-resistant technology. Acura said the FDA agreed to review the study and determine whether it could be used to support a new drug application.
The FDA released documents about the device, called Watchman, ahead of a meeting on Wednesday of outside medical experts who will consider its risks and benefits and then recommend whether the FDA should approve the product for use in patients.
Dec 9- Boston Scientific Corp's anti-stroke device did not meet one measure of success in a clinical study of the implant, but other data must be considered when determining overall safety and effectiveness, staff members of the U.S. Food and Drug Administration stressed on Monday.
Dec 9- Acura Pharmaceuticals Inc said the U.S. Food and Drug Administration agreed to review the results of a failed mid-stage trial of a painkiller made with the company's technology designed to deter abuse.
*AbbVie, InterMune say they defending business secrets. The decision leaves in limbo a high-profile fight that has pitched the European Medicines Agency, Europe's equivalent of the U.S. Food and Drug Administration, against AbbVie and InterMune.
WASHINGTON-- The Food and Drug Administration said Wednesday that it reached a $1.25 million settlement with a division of Johnson& Johnson over allegations that it knowingly shipped faulty sterilization equipment used by hospitals.
NEW YORK-- Shares of Intuitive Surgical came under pressure Wednesday after a warning about a stalling problem that has affected a few of its robotic surgical systems. While the company disclosed the problem on Nov. 19, it was posted to the website of the Food and Drug Administration on Tuesday.
NEW YORK-- Shares of Intuitive Surgical fell Wednesday on a warning about a stalling problem that has affected a few of its robotic surgical systems. While the company disclosed the problem on Nov. 19, it was posted to the website of the Food and Drug Administration on Tuesday.
The FDA the following month declared a Class II recall on the devices, citing a "remote" chance of severe adverse consequences or death due to the product flaw. FDA spokeswoman Jennifer Rodriguez said the agency issued its safety advisory on Tuesday because Philips has been unable to reach a significant number of its customers, to point out the potential risk.
NEW YORK-- Shares of Ambit Biosciences tumbled Wednesday after the company said it won't file for accelerated approval of its leukemia drug quizartinib, and will run a late-stage clinical trial instead. The company has been meeting with the Food and Drug Administration to discuss quizartinib, a potential treatment for acute myeloid leukemia.
Dec 4- Oculus Innovative Sciences Inc's shares more than doubled after the U.S. Food and Drug Administration approved the company's anti-scar treatment for raised and red scars resulting from burns, surgical procedures and trauma wounds. This is the eighth FDA approval for Microcyn-based products, Oculus CEO Jim Schutz said in a statement on Wednesday.
CAMBRIDGE, Mass.-- Biogen Idec said Monday the Food and Drug Administration extended its review of Alprolix, a drug designed to treat hemophilia B. Biogen Idec said the FDA extended its review by three months. Biogen Idec Inc. shares closed at $290.97 on Friday, and they rose 13 cents to $291.10 in premarket trading.
Dec 2- Biogen Idec Inc on Monday said the U.S. Food and Drug Administration will extend by three months its deadline for reviewing the company's experimental long-acting medicine for hemophilia.
These data do not confirm the signal of increased risk of heart attacks that was found in an analysis of previous clinical trials first reported in 2007, the FDA said in a statement. "GSK welcomes the decision of the FDA and appreciates the agency's robust review of the science with regard to Avandia," Glaxo said in an emailed statement.
These data do not confirm the signal of increased risk of heart attacks that was found in an analysis of previous clinical trials first reported in 2007, the FDA said in a statement. GlaxoSmithKline could not immediately be reached to comment on the FDA decision.
Nov 25- U.S. health regulators on Monday said they would lift restrictions on the use of GlaxoSmithKline Plc's once widely used diabetes drug Avandia after determining that it did not increase the risk of heart attacks.
*FDA: tests have not received marketing clearance. In a warning letter dated Nov. 22 and released on Monday, the FDA said products that are designed to diagnose, mitigate or prevent disease are medical devices that require regulatory clearance or approval, "as FDA has explained to you on numerous occasions."