With rising food rates and an increase in food imports, food fraud is a growing problem that costs the industry up to $15 billion a year.» Read More
FDA said GSK did not fully investigate a list of objectional conditions the regulator sent after its inspection of the manufacturing plant at Cork, Ireland in October. The FDA said its investigator found that a certain drug ingredient, the name of which was not disclosed, was contaminated with material from the plant's pharmaceutical waste tank.
April 1- Intuitive Surgical Inc said the U.S. Food and Drug Administration approved for marketing an upgraded version of its flagship robotic surgical system, sending the company's shares up as much as 15 percent. Intuitive Surgical launched its last major upgrade of the da Vinci system in 2009..
April 1- The U.S. Food and Drug Administration found contamination of drug ingredients manufactured at a GlaxoSmithKline Plc plant in Ireland and said the company did not take sufficient action to resolve the problems.
March 31- Durata Therapeutics Inc's drug to treat acute bacterial skin infections shows substantial evidence of safety and efficacy, a panel of advisers to the U.S. Food and Drug Administration concluded on Monday. The FDA is not obliged to follow the advice of its expert panels but typically does so.
March 31- Durata Therapeutics Inc's drug to treat acute bacterial skin infections shows substantial evidence of safety and efficacy, a panel of advisers to the U.S. Food and Drug Administration concluded on Monday. The panel voted unanimously in favor of the drug, dalbavancin, paving the way for its approval.
March 31- Curis Inc said the U.S. Food and Drug Administration allowed it to resume testing of its experimental cancer drug, lifting a November order halting enrolment in an early-stage trial. Curis acquired the license to develop and market the treatment from Genentech, a unit of the Roche Holding AG, for an upfront payment of $9.5 million in November 2012.
March 31- Curis Inc said the U.S. Food and Drug Administration allowed it to resume testing its experimental cancer drug, lifting a November order halting enrolment in an early-stage trial. The company's shares jumped about 22 percent to $3.35 in trading before the bell. The Lexington, Massachusetts- based company's shares closed at $2.75 on the Nasdaq on Friday.
March 28- Biogen Idec Inc has won U.S. approval for its long-acting hemophilia B treatment Alprolix, the U.S. Food and Drug Administration said on Friday. It affects about 4,000 people in the United States and 25,000 worldwide.
March 27- Alimera Sciences Inc said it has applied a fourth time for U.S. regulatory approval to start selling an eye implant that delivers a drug to treat a form of blindess in diabetes patients. The FDA asked for a new trial of the drug-device combination, but Alimera's partner, Psivida Corp, said that additional trials were not necessary.
March 26- Some bottles of Alli, GlaxoSmithKline Plc's weight-loss drug sold over the counter in the United States, have been tampered with, and the Food and Drug Administration was investigating, the company said on Wednesday.
March 26- GlaxoSmithKline Plc said some bottles of its weight-loss drug Alli bought in the United States had been tampered with and that the U.S. Food and Drug Administration was investigating. Consumers reported that some bottles bought in stores in seven states contained products other than the drug, the company said on Wednesday.
The halt announced on Thursday was for enrollments in a trial sponsored by Mayo Clinic, and comes a week after the FDA ordered Geron to cease company-sponsored trials of the drug over similar concerns. The FDA on March 12 had ordered a complete halt to trials that were testing imetelstat to treat thrombocythemia and multiple myeloma, two forms of blood cancer.
March 18- Biogen Idec Inc said the U.S. Food and Drug Administration extended the review process for the company's multiple sclerosis drug by three months to evaluate the application. Biogen, which was expecting to launch the drug, Plegridy, by mid-2014, said the FDA did not ask for additional studies. Biogen shares closed at $345.60 on Monday on the Nasdaq.
WASHINGTON/ NEW YORK, March 18- Some U.S. doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.
March 17- Staar Surgical Co said an independent advisory panel to the Food and Drug Administration recommended marketing approval for its implantable lens, bringing it closer to a long-awaited U.S. launch and sending the company's shares up 27 percent.
March 17- Staar Surgical Co said an independent advisory panel to the U.S. Food and Drug Administration recommended marketing approval for its implantable vision-correction lens, sending the company's shares up 22 percent in premarket trade on Monday.
March 13- Venaxis Inc said its appendicitis test correctly predicted results in 97 percent of patients in a clinical trial, sending its shares up 25 percent in premarket trade. The company said it expected to finalize its marketing application and submit it to the U.S. Food and Drug Administration in the next few weeks.
*Shares fall more than 6 percent after FDA sanction. The FDA has imposed a rash of regulatory sanctions on Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by the $14 billion industry to countries including the United States, the biggest market. "The FDA is becoming more stringent.
March 12- Geron Corp said the U.S. Food and Drug Administration ordered a halt to trials of its cancer drug imetelstat over concerns about potential liver damage, sending the company's shares plunging almost 60 percent before the bell.
March 11- Senomyx Inc said the U.S. Food and Drug Administration had declared that its Sweetmyx food flavoring was safe, paving the way for customers such as PepsiCo Inc to add it to drinks to reduce the use of sugar and sugar substitutes.