The single-dose medicine "represents important progress" as the first-ever gene therapy for the rare disorder, the FDA said. ”The Food and Drug Administration cleared Hemgenix, an IV treatment for adults with hemophilia B, the less common form of the genetic disorder which primarily affects men.”
Source: cbsnews.com
Artificial intelligence yields new antibiotic: A deep-learning model identifies a powerful new drug that can kill many species of antibiotic-resistant bacteria.
“The idea of using predictive computer models for “in silico” screening is not new, but until now, these models were not sufficiently...
Source: mit.edu
Publication bias is a challenge in science and a criticism of the influence of industry. In the domain of biosciences and drug development more accountability (e.g. the FDAAA 2007), editorial and peer-review training (as suggested by the Cochrane Collaboration), and statistical techniques (as championed...
Cardiologs Cloud-Based Software FDA Cleared to Spot Arrhythmias in ECGs |: Cardiologs, a company based in Paris, France, won FDA clearance for its software that analyzes electrocardiograms (ECG) for signs of cardiac arrhythmias. T
Source: medgadget.com
The cruel sham that is right-to-try raises its ugly head at the federal level again: Ill-advised right-to-try bills are spreading like kudzu through state legislatures. Now federal legislators want to insert right-to-try language into the bill that funds FDA drug approval. Given th…
Source: sciencebasedmedicine.org
Yomi, The First Robotic Dental Surgery System Now Cleared by FDA |: Neocis, a company based in Miami, Florida, just announced winning FDA clearance to introduce Yomi, the first robotically assisted dental surgical system. Y
Source: medgadget.com
CardioInsight ECG Vest for Non-Invasive, Precise Heart Maps |: Medtronic landed FDA clearance for its CardioInsight 3D cardiac mapping system that's used to locate sources of arrhythmias. The system consists of an ECG
Source: medgadget.com
Essential Tremor, Tremor Dominant Parkinson's Disease, Neuropathic Pain Treatment | INSIGHTEC "Exablate Neuro, is the first focused ultrasound device approved by the FDA to treat patients with essential tremor. Exablate Neuro is a non-invasive, image-guided personalized thalamotomy, treated through...
Source: insightec.com
Moderately Obese Patients Benefit from Vagal Nerve Blockade Using vBloc Neurometabolic Therapy |: Medgadget previously reported on the first U.S. implantation of the vBloc Neurometabolic Therapy system, an FDA-approved medical device for treating obesit
Source: medgadget.com
Press Announcements - FDA approves first leadless pacemaker to treat heart rhythm disorders: The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While...
Source: fda.gov
Can smartphone drug trials improve medical care?: A new clinical trial is attempting to track how participants suffering from depression respond to mental health apps
Source: theguardian.com
FDA Approves Less Expensive Insulin Glargine: By Kristin J. Kelley
Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
The FDA has approved an insulin glargine injection (marketed as Basaglar) for treating type 1 (adult and pediatric patients) and … NEJM Journal Watch.
Source: jwatch.org
FDA Approves Two New Treatments for Diabetes NEJM Journal Watch.
Source: jwatch.org
Gliptins and Cardiovascular Outcomes: A Comparative and Critical Analysis after TECOS: The issue related to macrovascular outcomes and intensive glycemic control was hotly debated after the publication of landmark trials like ACCORD, ADVANCE, and VADT. The only benefits seem to come from intervening...
Source: hindawi.com