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Tag: approves

FDA approves first non-opioid withdrawal treatment

FDA approves first non-opioid withdrawal treatment

Health
May 17 (UPI) -- The U.S. Food and Drug Administration said it's approved for the first time a non-opioid drug for treatment of opioid withdrawal. The FDA said the drug Lucemyra, made by US WorldMeds, can be used as part of a long-term treatment for managing opioid use disorder. It treats narcotic withdrawal symptoms like vomiting, muscle aches, diarrhea, anxiety, sleep problems and sweats. "We're dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids," FDA Commissioner Dr. Scott Gottlieb said in a statement. "We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction." In 2016, two-thirds of drug overdose deaths in...
State Dept. approves $1.2B sale of helicopters, missiles to Mexico

State Dept. approves $1.2B sale of helicopters, missiles to Mexico

Business
April 23 (UPI) -- The U.S. State Department said it has approved a possible foreign military sale to Mexico for MH-60R Seahawk multi-mission helicopters, and missiles, radars and machine guns to go with them.The deal, announced Friday by the Defense Security Cooperation Agency, is worth $ 1.2 billion and requires Congressional approval before the contract is finalized. Members of Congress were notified of the potential foreign military sale last week.DSCA says the Government of Mexico requested the purchase of eight MH-60R Seahawk multi-mission helicopters, equipped with specific mechanical specifications and on-board technology systems designed for advanced targeting and night operations.Moreover, Mexico requested 10 AGM-114 Hellfire missiles, five AGM-114 M36-E9 Captive Air Training miss...
FDA approves Opdivo, Yervoy combination for kidney cancer

FDA approves Opdivo, Yervoy combination for kidney cancer

Health
April 17 (UPI) -- The Food and Drug Administration has approved a combination of two immunotherapy drugs, ipilimumab and nivolumab, to treat metastatic kidney cancer.The FDA approved the injection combination Monday based on the CheckMate 214 trial. The Phase 3 trial results were published Monday in the New England Journal of Medicine.The lifetime risk for developing kidney cancer is 1 in 48 among men and 1 in 83 among women, according to the American Cancer Society. And about 14,970 people will die each year because of the disease in the United States."The approval of this combination immunotherapy is the most significant advance for the treatment of kidney cancer over the last 10 years," study leader Dr. Hans Hammers, co-head of the Kidney Cancer Program at University of Texas Southweste...
State Dept. approves $1.3B sale of Howitzers to Saudi Arabia

State Dept. approves $1.3B sale of Howitzers to Saudi Arabia

Business
April 6 (UPI) -- The U.S. State Department said it has approved a possible foreign military sale to Saudi Arabia of 155mm M109A5/A6 Medium Self-Propelled Howitzer structures.The Defense Security Cooperation Agency notified Congress of the $ 1.31 billion sale, for which Raytheon and Lockheed Martin are the primary contractors. Congress was notified of the possible sale on Thursday.The possible foreign military sale would provide Saudi Arabia with "180 155mm M109A5/A6 Medium Self-Propelled Howitzer structures for conversion to 177 M109A6 Paladin Howitzer systems."The M109A6 Paladin Howitzer system is a self-propelled, indirect-fire support weapon operated by a crew of four.The deal also includes three Fire Support Combined Arms Tactical Trainers static training, 180 M2 HB .50 Cal Machine Gun...
NIH approves clinical trials for vaccine against avian influenza

NIH approves clinical trials for vaccine against avian influenza

Health
March 16 (UPI) -- A federal agency is recruiting volunteers for two Phase 2 clinical trials for a vaccine against H7N9, a strain of avian influenza that has not reached humans in the United States.The National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, wants an effective vaccine ready for any H7N9 pandemics.The trials, which will last 16 months, will test the effectiveness of different dosages of the inactivated influenza vaccine candidate, called 2017 H7N9 IIV, in conjunction with other vaccines.The virus strain was first reported in humans in 2013 in China. Subsequently, six waves of H7N9 infection have occurred there, resulting in 1,565 human infections and 613 deaths, according to the World Health Organization in January.Right now,...