by Linda A. Johnson U.S. regulators Wednesday approved a new tuberculosis medicine that shortens and improves treatment for the hardest-to-treat cases, a worsening problem in many poor countries. It’s the first TB drug from a nonprofit group. The TB Alliance, formed to come up with better treatments, developed pretomanid with help from charities and government...
Tag: <span>FDA</span>
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Miracle mineral solution’ is no miracle cure, FDA warns
The agency has not approved the product for any use, but it is marketed on social media as a remedy for autism, cancer, HIV/AIDS, hepatitis, influenza, and other conditions. When mixed, the solution develops into a dangerous bleach. The FDA has received recent reports of people developing severe vomiting, severe diarrhea, life-threatening low blood pressure...
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FDA approves 9 generic versions of nerve pain drug Lyrica
by Linda A. Johnson The U.S. Food and Drug Administration has approved the first generic copies of a popular, pricey pill for nerve pain. The agency on Monday said it approved nine generic versions of Pfizer Inc.’s Lyrica. It is also used for seizures and fibromyalgia, a condition that causes chronic, widespread pain. Lyrica, approved...
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FDA approves first noninjection glucagon therapy
Baqsimi nasal powder, which was approved for patients with diabetes who are 4 years and older, is available in a single-use dispenser containing a recommended dose of 3 mg. Approval was based on two studies of adult patients and one study in children—all comparing a single dose of Baqsimi to a single dose of glucagon injection. In all three...
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FDA approves first needle-free ‘Rescue’ drug for low blood sugar episodes
by E.j. Mundell, Healthday Reporter (HealthDay)—In what could prove to be a real advance for Americans with diabetes, the U.S. Food and Drug Administration on Wednesday gave the nod to a needle-free method of helping people recover from an episode of dangerous low blood sugar. The new formulation, called Baqsimi, contains the rescue medication glucagon,...
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Five Day Long Scan of Complete Brain Using Ultra Powerful MRI
JULY 11TH, 2019 MEDGADGET EDITORS NEUROLOGY, RADIOLOGY Two years ago the FDA issued the first clearance for a high-field MRI scanner, the Siemens MAGNETOM Terra. Featuring a 7 Tesla magnet, the device generates a magnetic field more than twice the strength of the 3 Tesla scanners that were previously the most powerful for clinical use. Now, a team of researchers,...
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Five things found in the FDA’s hidden device database
by Sydney Lupkin, Kaiser Health News After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration has published the once hidden database online, revealing 5.7 million incidents publicly for the first time. The newfound transparency follows a Kaiser Health News investigation that revealed device manufacturers, for the past two...
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Nanodrugs
Nanodrugs have been around for some time. In fact, over 250 drugs using nanotechnology that have been approved by the FDA and are in clinical use. The name nanodrug or nanopharmaceuticals refers to the size of the particle that is created to house the medication. A nano is very tiny: nanoparticles are between 1 and 100 nanometers...
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FDA approves new multiple myeloma drug despite toxicity concerns
The Food and Drug Administration on Wednesday approved a new drug to treat patients with multiple myeloma, overruling a panel of outside cancer experts who expressed concerns about its toxicity. The new multiple myeloma drug, called selinexor, will be marketed by Karyopharm Therapeutics under the brand name Xpovio. The FDA cleared Xpovio under an accelerated,...
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Synthetic joint lubricant holds promise for osteoarthritis
by Krishna Ramanujan, Cornell University A new type of treatment for osteoarthritis, currently in canine clinical trials, shows promise for eventual use in humans. The treatment, developed by Cornell University biomedical engineers, is a synthetic version of a naturally occurring joint lubricant that binds to the surface of cartilage in joints and acts as a cushion during high-impact activities, such as running. “When...