Senseonics, a company out of Germantown, Maryland, won FDA approval for its Eversense continuous glucose monitoring system. The system is intended to be used instead of traditional fingerprick tests to make diabetes-related decisions. This is a giant step for the company, which has developed a technology that combines a tiny implant with a wearable transmitter to continuously measure glucose for 90 days at...
Tag: <span>FDA</span>
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Electronic Device Cleared by FDA to Treat Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a complex condition with a number of potential causes, symptoms, and treatment options. While experienced in the gut, IBS often seems to be related to a poorly functioning nervous system. Specifically, the signals that the gut sends can be perceived by the brain as being abnormal, resulting in sensations of...
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FDA approves venetoclax for chronic, small lymphocytic leukemia
Data from CLL14, a randomized, multicenter, open-label, actively controlled trial, provided the basis for approval. CLL14 involved 432 patients with previously untreated CLL and coexisting medical conditions who were randomly assigned to venetoclax plus obinutuzumab (VEN+G) or obinutuzumab plus chlorambucil (GClb). The researchers observed a statistically significant improvement in progression-free survival for patients who received VEN+G compared with those...
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Cancer drug approved for NHS use in England gives some multiple myeloma patients another option
by Cancer Research UK A drug has been made available on the NHS in England for adults with a type of blood cancer called multiple myelomawho cannot receive standard treatment. The National Institute for Health and Care Excellence (NICE) recommended the drug, lenalidomide (Revlimid), be offered in combination with the steroid dexamethasone. But only for those who cannot take the current thalidomide-based standard of care or are not able to have...
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Software Listens to Stethoscope to Classify Heart Sounds: Now FDA Cleared
eMurmur, a Canadian firm, just won FDA clearance for its eMurmur ID system that spots and classifies heart murmurs, as well as S1, S2 heart sounds. The offering, the core of which resides in the cloud, relies on sounds recorded using a third-party electronic stethoscope. The user simply pairs a Bluetooth-capable stethoscope to a smartphone running the eMurmur ID app and performs an auscultation. The app...
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Benlysta approved for children with lupus
(HealthDay)—The intravenous drug Benlysta (belimumab) has been approved by the U.S. Food and Drug Administration to treat children with lupus, a chronic disease that triggers inflammation and damages tissues and organs throughout the body. Approved for adults since 2011, Benlysta is the first lupus treatment in the United States approved for children, the agency said in a news release. “While there is no cure for lupus, treatment can help our youngest...
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Generic Anti-Overdose Nasal Spray Gets FDA Approval
To combat the problem of increasing death rate in the United States due to opioid overdose, the FDA has approved a generic variant of naloxone. Naloxone is a drug used to rapidly reverse the effects of an opioid overdose and prevent death. The medication will come in the form of a nasal spray and it will be easily administered by anyone to help a patient who...
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Cimzia injection approved for new inflammatory arthritis indication
(HealthDay)—Cimzia (certolizumab pegol) injection has been approved to treat adults with nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, the U.S. Food and Drug Administration announced. The injection is the first treatment approved for nr-axSpA. Approval was based on data from a randomized clinical trial of 317 adult patients with nr-axSpA and objective signs of inflammation as indicated by magnetic resonance imaging showing elevated C-reactive protein levels...
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Ketamine works great for depression and other conditions, and costs $10/dose; the new FDA-approved “ketamine” performs badly in trials and costs a fortune
Ketamine is a sedative first synthesized in 1962; its patents have long elapsed and it costspennies; it has many uses and is also sold illegally for use as a recreational drug, but in recent years it has been used with remarkable efficacy as a treatment for a variety of disorders, including depression, anxiety, and chronic pain (I have...
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FDA warns Americans not to buy drugs from Canadian company
CanaRx sells common prescription medicines at a lower cost to hundreds of public and private employer programs in the United States, including city and county governments trying to save money, The New York Times reported. The company says it provides high-quality medications from Canada, Australia, and Britain, but the FDA says that is not always the case. “Operations like CanaRx use their names...