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Government Agencies FDA

  • LONDON, Sept 5- French cell therapy specialist Cellectis, which is developing a gene-modified cancer treatment similar to Novartis's recently approved Kymriah, has been forced to suspend testing following a patient death. Cellectis said on Tuesday it was working closely with the U.S. Food and Drug Administration in order to resume trials with a lower dose of...

  • Sept 1- The U.S. Food and Drug Administration on Friday approved Pfizer Inc's drug, Mylotarg, for certain patients with acute myeloid leukemia, re-clearing a drug that had been pulled off the market in 2010.. The FDA said the drug has a boxed warning as it may cause severe or fatal liver damage, including blockage of veins in the liver. Friday's approval includes a...

  • Sept 1- The U.S. Food and Drug Administration on Friday approved Pfizer Inc's drug, Mylotarg, for certain patients with acute myeloid leukemia. The FDA said the drug has a boxed warning as it may cause severe or fatal liver damage, including blockage of veins in the liver. Friday's approval includes a lower recommended dose, a different dosing schedule and a new...

  • Sept 1- The U.S. Food and Drug Administration on Friday approved Pfizer Inc's drug, Mylotarg, for certain patients with acute myeloid leukemia. The drug was cleared to treat adults with newly diagnosed AML whose tumors express the CD33 antigen, as well as patients aged 2 years and older with CD33-positive AML who have relapsed, or did respond to initial treatment.

  • Aug 30- The U.S. Food and Drug Administration on Wednesday gave a green light to Novartis AG's leukemia treatment, marking the first time that a highly anticipated new type of potent gene-modifying immunotherapy has gained approval in the United States. "Were entering a new frontier in medical innovation with the ability to reprogram a patients own cells to...

  • Aug 30- The U.S. Food and Drug Administration on Wednesday approved Novartis AG's keenly anticipated leukemia treatment, marking the first gene therapy approval in the United States. The drug, Kymriah, was approved for patients up to 25 years of age suffering from B-cell acute lymphoblastic leukemia, who have relapsed or failed chemotherapy.

  • NEW YORK, Aug 29- Abbott Laboratories said on Tuesday it would issue updates to reduce the risk of its St. Jude recalled some of its 400,000 implanted heart devices last October due to risk of premature battery depletion, which was linked to two deaths in Europe. The U.S. Food and Drug Administration said then that hospitals should return unused devices and warned...

  • NEW YORK, Aug 29- Abbott Laboratories said on Tuesday it will issue updates to reduce the risk of its St. Jude recalled some of its 400,000 implanted heart devices last October due to risk of premature battery depletion, which was linked to two deaths in Europe. The U.S. Food and Drug Administration said then that hospitals should return unused devices and warned...

  • NEW YORK, Aug 29- Abbott Laboratories said on Tuesday it will issue updates to reduce the risk of its St. Jude recalled some of its 400,000 implanted heart devices last October due to risk of premature battery depletion, which was linked to two deaths in Europe. The U.S. Food and Drug Administration said then that hospitals should return unused devices and warned...

  • A small number of "unscrupulous actors" have seized on the promise of regenerative medicine and stem cell therapies to mislead patients based on unproven, and in some cases, dangerously dubious products, the FDA said on Monday. The FDA said it had taken steps to tackle the problem of some "troubling products" being marketed in Florida and California.

  • Aug 28- The U.S. Food and Drug Administration is stepping up efforts to better regulate an emerging field of medicine that holds significant promise for curing some of humanity's most troubling maladies by using the body's own cells. A small number of "unscrupulous actors" have seized on the promise of regenerative medicine to mislead patients based on...

  • Aug 25- Novo Nordisk said on Friday the U.S. Food and Drug Administration approved an expanded use of its diabetes drug to reduce the risk of cardiovascular events such as heart attack and stroke. This is the first time the FDA has cleared a diabetes drug for reducing risks of heart attack, stroke and cardiovascular deaths in patients with type 2 diabetes, the...

  • Aug 25- Novo Nordisk said on Friday the U.S. Food and Drug Administration approved an expanded use of its diabetes drug to reduce the risk of cardiovascular events such as heart attack and stroke. Heart disease is the leading cause of death in the United States, killing about 610,000 people every year, according to the Centers for Disease Control and Prevention.

  • Aug 25- Novo Nordisk said on Friday the U.S. Food and Drug Administration approved its diabetes drug as a treatment to reduce the risk of three major cardiovascular diseases. This is the first time the FDA has cleared a diabetes drug to treat heart-related diseases in patients with type 2 diabetes, the company said in a statement. Heart disease is the leading cause...

  • Aug 24- The U.S. Food and Drug Administration said it had approved Adamas Pharmaceuticals Inc's treatment for a side effect caused by a commonly prescribed Parkinson's drug, sending the shares of the drugmaker soaring in after-market trading. Adamas' Gocovri, previously ADS-5102, is the first drug cleared by the FDA to control levodopa-induced dyskinesia.

  • Dr. Scott Gottlieb

    "It's not the nicotine that kills you, it's all the other carcinogens in lighting tobacco on fire," FDA Commissioner Dr. Scott Gottlieb says.

  • Branded companies slowing generic drugs' path to market: FDA's Scott Gottlieb

    Scott Gottlieb, Food and Drug Administration commissioner, talks about looking at ways to improve the generic drug approval process, issues of drug pricing and competition, and addressing the opioid crisis.

  • FDA's plan to reduce nicotine levels: Scott Gottlieb

    Scott Gottlieb, Food and Drug Administration commissioner, talks about the agency's plan to introduce regulation that lowers nicotine levels.

  • LONDON, Aug 21- Britain's Creo Medical Group said its device to remove cancerous lesions in the bowel during an endoscopy had received U.S. approval much quicker than it planned, shaking up a timetable that had been focused on a European launch. The company, which listed late last year, said the U.S. Food and Drug Administration had cleared its Speedboat RS2 device...

  • Aug 17- The U.S. Food and Drug Administration on Thursday expanded the use of Lynparza, sold by AstraZeneca Plc and Merck& Co Inc, to include ongoing treatment of patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. The agency also approved a new two-tablet regimen for the drug, regardless of whether patients test positive...