by Matthew Perrone U.S. health regulators are warning that popular nervous system medications can cause dangerous breathing problems when combined with opioids and certain other drugs. The Food and Drug Administration said Thursday it would add new warnings to packaging for Neurontin, Lyrica and generic versions, which are used to treat seizures, nerve pain, restless...
Tag: <span>FDA approved Medical device</span>
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Penn uncovers dose of medication more likely to put patients with pemphigus into remission
Findings may inform use of recent FDA-approved drug rituximab to better treat patients with pemphigus UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE PHILADELPHIA – Pemphigus, an autoimmune disease mediated by B cells and which causes painful blisters and sores on the skin and mucous membranes, is a rare chronic autoimmune condition that can be fatal if...
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GenMark Fungal Blood Culture Test Clears FDA
NEW YORK (GenomeWeb) – GenMark Diagnostics announced today it has received 510(k) clearance from the US Food and Drug Administration for a molecular diagnostic panel assay to detect fungal pathogens from blood cultures of patients with suspected blood stream infections. The test is called the ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel. It runs...
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Bladder control via gene therapy?
What are the limits of gene therapy? “There are no currently available FDA-approved gene therapy treatments for overactive bladder,” reads this press release. And that’s true. But is it, like, a problem? Urovant Sciences believes so, which is why it licensed just such a gene therapy for overactive bladder. It’s called hMaxi-K, and it targets...
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Cancer drug earns FDA nod after decades
Duncan Hunter chokes up a little when it is suggested that work he began at Western three decades ago will now, finally, be applied to saving hundreds of lives. “It’s a good thing,” said the Chemistry professor emeritus after a long pause. “It took 30 years and had its ups and downs. So, yes, it’s...
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FDA OKs first drug made to reduce excessive sweating
June 29, 2018 by Linda A. Johnson The U.S. Food and Drug Administration has approved the first drug developed specifically to reduce excessive sweating, a common condition that can cause anxiety. Dermira Inc. said Friday its Qbrexza (cue-BREX’-zah) was approved for excessive underarm sweating. The drug is inside a cloth wiped over the skin daily...
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‘FDA approved’ medical devices don’t actually have to do what they promise
‘FDA approval’ has a certain glow of authority to it. In most people’s minds to be FDA approved is to be safe, effective, and proven. Or at least, it technically is. Technically, FDA approval is a stringent process that requires a degree of proof. You might like to think that you couldn’t get away with claiming something went through that...