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Government Agencies FDA

  • However, the FDA said it does not consider the supplementary information that is consistent with the FDA- required labeling guidelines alone to be evidence of a new intended use. If a firm communicates information, including on promotional material, that has not been evaluated by the regulator, but appears to be FDA- ratified, then it could lead to misbranding, and...

  • On Tuesday, British American Tobacco Plc announced a $49- billion deal to take over rival Reynolds American Inc, uniting two major e-cigarette players in the United States and United Kingdom and becoming a bigger competitor to Philip Morris International Inc and U.S. partner Altria Group. "Suddenly things that were not conceivable became something we...

  • If a firm communicates information, including on promotional material, that has not been evaluated by the regulator, but appears to be FDA- ratified, then it could lead to misbranding, and could subject firms to enforcement action if the representations or suggestions are considered false or misleading. To avert this, the FDA recommended on Wednesday that...

  • Jan 17- The U.S. Food and Drug Administration said it had approved the first generic version of Xyrem, Jazz Pharmaceuticals Plc's drug to treat patients with narcolepsy, a kind of sleeping disorder. The approved generic is developed by Roxane Laboratories Inc, the FDA told Reuters. About 70 percent people with narcolepsy suffer from cataplexy, the FDA said.

  • Jan 17- The U.S. Food and Drug Administration said on Tuesday it had approved the first generic version of Xyrem, Jazz Pharmaceuticals Plc's drug to treat patients with a medical condition that causes excessive daytime sleepiness.

  • Jan 17- Alcobra Ltd said it would abandon evaluating its only experimental drug to treat attention deficit hyperactivity disorder, after a failed late-stage study, wiping away more than half the company's value before the bell on Tuesday. Yaron Daniely said on a conference call. The U.S. Food and Drug Administration earlier this month recommended Alcobra...

  • Jan 17- Alcobra Ltd said on Tuesday its experimental attention deficit hyperactivity disorder therapy failed a late-stage study in adult patients and the company's shares plunged about 44 percent in premarket trading. The U.S. Food and Drug Administration earlier this month recommended that Alcobra conduct a new MDX trial to expel safety concerns...

  • Jan 17- Israeli drug developer Alcobra Ltd on Tuesday said its experimental drug to treat attention deficit hyperactivity disorder failed a late-stage study in adult patients. The announcement follows the recommendation of the U.S. Food and Drug Administration this month that the company conduct a new MDX trial to expel safety concerns emanating from...

  • Rep. Tom Price, R-Ga.

    Price and Rep. Chris Collins, R-N.Y., got a 12 percent discount in their private placement purchase of stock in an Australian drug company.

  • Jan 9- Canada's Valeant Pharmaceuticals International Inc said its affiliate will sell its Dendreon cancer business to China's Sanpower Group Co Ltd for $819.9 million, as the drugmaker continues to shed its non-core assets to repay debt. Dendreon makes prostate cancer vaccine Provenge that was approved by the U.S. Food and Drug Administration in 2010..

  • The Food and Drug Administration and the Department of Homeland Security said that St. The patch that Abbott began pushing out to patients on Monday addresses vulnerabilities that present the greatest risk to patients and prevent hackers from accessing the device, said FDA spokeswoman Angela Stark. "The FDA has maintained this focus on addressing patient...

  • Jan 9- The U.S. Food and Drug Administration on Monday approved Egalet Corp's long-acting opioid painkiller, Arymo ER, and will allow the company to claim it deters abuse by those seeking to dissolve and inject it. The FDA typically follows the advice of its advisory panels but is not obliged to do so. The FDA said in a statement that an extended-release morphine...

  • Jan 9- The U.S. Food and Drug Administration said on Monday it has approved Egalet Corp's long-acting opioid painkiller, Arymo ER. The decision follows the recommendation of an independent panel of advisors to the FDA, which in August voted 18-1 in favor of approval. The FDA did not immediately say whether it has granted the abuse-deterrent label.

  • Jan 9- The U.S. Food and Drug Administration said on Monday it has approved Egalet Corp's long-acting opioid painkiller, Arymo ER. FDA in August voted 18-1 in favor of approval and recommended the drug be labeled as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse. http://bit.ly/2jv97Ld. Lawmakers across the United States are...

  • Jan 9- Abbott Laboratories said on Monday it has begun releasing cyber security updates for its St. Abbott announced the updates as the U.S. Food and Drug Administration issued a Safety Communication advising patients and physicians to keep using the company's implanted cardiac devices following the updates. "The FDA conducted an assessment of the benefits...

  • FOOD AND DRUG ADMINISTRATION RELEASES SAFETY COMMUNICATION ON ABBOTT'S ST JUDE MEDICAL DEVICES.

  • The company said it would submit a supplemental marketing application with the U.S. Food and Drug Administration in the first half of 2017.. Otiprio, which was approved in late 2015, generated sales of $300,000 in the third quarter of 2016.. There are nearly 4 million cases of AOE each year in the United States, according to the company.

  • A pedestrian carries an umbrella while walking along Wall Street past the New York Stock Exchange in New York.

    These are the stocks posting the largest moves after the bell on Thursday, including: Mylan, Lockheed Martin and more.

  • *FDA asks for bigger study. The FDA did not ask for further data on solithromycin's effectiveness in treating CABP, Cempra said. An independent FDA panel narrowly backed the drug, solithromycin, in November, although a preliminary staff review by FDA scientists highlighted a potentially concerning rise in liver enzymes associated with its use.