Government Agencies FDA

  • 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.

  • The FDA, in its complete response letter, did not ask for further data on solithromycin's effectiveness in treating CABP, Cempra said on Thursday. An independent panel to the FDA narrowly voted in November in favor of the drug, solithromycin, although in a staff review FDA scientists highlighted a potentially concerning rise in liver enzymes associated with...

  • An independent panel to the FDA narrowly voted in November in favor of the drug, solithromycin, although in a staff review FDA scientists highlighted a potentially concerning rise in liver enzymes associated with its use. The FDA, in its complete response letter, did not ask for further data on solithromycin's effectiveness in treating CABP, Cempra said on...

  • FDA in November narrowly voted in favor of the drug, solithromycin, although in a staff review, FDA scientists highlighted a potentially concerning rise in liver enzymes associated with its use. On Thursday, the FDA did not request any further information on solithromycin's effectiveness in treating CABP, Cempra said. Ketek was approved by the FDA in 2004, but...

  • Dec 27- Seattle Genetics Inc said four people had died in trials testing its experimental cancer drug, prompting the U.S. Food and Drug Administration to impose a clinical hold on several early-stage studies. The company is working with the FDA to identify whether the drug is the cause of the toxicity. "This outcome does place risk on whether the program is able to...

  • Dec 27- Seattle Genetics Inc said four people had died in trials testing its experimental cancer drug, prompting the U.S. Food and Drug Administration to impose a clinical hold on several early-stage studies. The company's shares fell 14.6 percent to $52.85 in premarket trading. The company is working with the FDA to identify whether the drug is the cause of the...

  • Dec 27- Seattle Genetics Inc said on Tuesday that four people had died in trials testing its experimental cancer drug, prompting the U.S. Food and Drug Administration to impose a clinical hold on several early-stage trials. The drug, vadastuximab talirine, is being tested to treat acute myeloid leukemia, a type of blood cancer. Six patients have been identified...

  • Dec 27- Seattle Genetics Inc said on Monday that four people had died in trials testing its experimental cancer drug, prompting the U.S. Food and Drug Administration to impose a clinical hold on several early-stage trials. The drug, vadastuximab talirine, is being tested to treat acute myeloid leukemia, a type of blood cancer. Six patients have been identified...

  • It is the first FDA- approved medicine for spinal muscular atrophy, a devastating disease that affects about one in 10,000 live births. The FDA approved it for use across the full range and severity of the disease. Annual Spinraza sales could reach $2 billion, according to RBC Capital Markets analyst Michael Yee.

  • Dec 23- The U.S. Food and Drug Administration on Friday said it has approved Biogen Inc's drug to treat spinal muscular atrophy, the leading genetic cause of death in infants. The drug, nusinersen, which was discovered by Ionis Pharmaceuticals and licensed to Biogen, will be sold under the brand name Spinraza. It is the first FDA- approved medicine for spinal...

  • LOS ANGELES/ CHICAGO, Dec 22- U.S. sales and distribution of antibiotics approved for use in food-producing animals increased 1 percent from 2014 to 2015, the U.S. Food and Drug Administration said in a report on Thursday. In 2015, sales and distribution of those medically important antibiotics for food production rose 2 percent, the FDA said.

  • LOS ANGELES, Dec 22- U.S. sales and distribution of antibiotics approved for use in food-producing animals increased 1 percent from 2014 to 2015, the U.S. Food and Drug Administration said in a report on Thursday. In 2015, sales and distribution of those medically important antibiotics for food production rose 2 percent, FDA said. Tetracyclines accounted for 71...

  • Worker places the expiration date on milk products while working on the bottling line of South Mountain Creamery, in Middletown, Maryland.

    The USDA suggests that manufacturers and retailers opt for the phrasing "best if used by," Eater reports.

  • Acadia said a total of 181 patients were enrolled in the study in the UK and randomized on a one-to-one basis to receive either 34 mg of pimavanserin or placebo once everyday. The drug has been approved by the US Food and Drug Administration to treat hallucinations and delusions associated with Parkinson's disease psychosis, the company said.