Tag: FDA
Gene-silencing Technology Gets First Frug Approval After 20-year Wait
US regulators have approved the first therapy based on RNA interference (RNAi), a technique that can be used to silence specific genes linked to disease. The drug, "patisiran", targets a rare condition that can impair heart... read more
Intravenous Fish Oil (Omegaven) Approved by FDA
Intravenous Fish Oil (Omegaven) approved by FDA for use in total parenteral nutrition (TPN) in pediatric patients in the United States. Omegaven 10% Emulsion is a fish oil emulsion administered intravenously in patients who... read more
FDA Approves Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
FDA has approved Allergan's supplemental New Drug Application (sNDA) to expand the approved use of AVYCAZ® (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated... read more
FDA Approves Angiotensin-II for Septic Shock
The FDA approved angiotensin-II (Giapreza) as a new intravenous vasopressor for septic shock and other forms of distributive shock. The first new FDA-approved vasopressor in decades, angiotensin-II could significantly change... read more
A New Combination of Antibiotic and Inhibitor
Intensivists have another antibiotic combination to treat severe infections caused by gram-negative bacteria with the FDA’s approval of Vabomere (meropenem, combined with the beta-lactamase inhibitor called vaborbactam).... read more
Diagnostic Imaging on iPhone
FDA just cleared Butterfly Network's iQ an iPhone-connected Ultrasound system, which claims it is the world's first "ultrasound-on-a-chip" system. Butterfly iQ is FDA 510(k) cleared for diagnostic imaging across 13 clinical... read more
FDA approves betrixaban for VTE prophylaxis
Betrixaban, a factor Xa inhibitor, has been approved for the prophylaxis of venous thromboembolism (VTE) in at-risk adult patients hospitalized with an acute illness, according to an announcement from the Food and Drug Administration.... read more
FDA Approves Label Changes for Pediatric General Anesthetic and Sedation Drugs
The FDA has approved labeling changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. General anesthetic and sedation drugs are necessary for patients, including young children... read more
Drug-Free Musculoskeletal Pain Therapy Given Clearance by FDA
BioElectronics Corp. has received over-the-counter use market clearance from the FDA for ActiPatch for the adjunctive treatment of musculoskeletal pain related to plantar fasciitis of the heel and osteoarthritis of the knee. BioElectronics... read more
Pharmacists Can Make a Difference During Influenza Pandemics
Since November 2015, approximately 25% of adults who receive annual seasonal influenza vaccination are immunized in pharmacies or retail health care settings. The growth in vaccine uptake at pharmacies has public health policy... read more
In Hospital ICUs, AI Could Predict Which Patients Are Likely to Die
With streams of data coming from equipment that monitors patients’ vital signs, the ICU seems the perfect setting to deploy artificially intelligent tools that could judge when a patient is likely to take a turn for the... read more
This Handheld Ultrasound Scanner Could Be the Next Stethoscope
Clarius co-founder and CEO Laurent Pelissier believes the affordable, wireless device could revolutionize health care. The U.S. Food and Drug Administration approved the Clarius ultrasound scanner for use in December 2016,... read more
Transcatheter Aortic Valve Replacement in Younger Individuals
When a patient has an aortic valve that requires replacement because the native valve is diseased, 2 types of valves can be used - mechanical valves or bioprosthetic valves, also known as tissue valves. Bioprosthetic valves... read more
FDA Recommendation: Reduce Max Storage Limit of RBCs
A group of researchers are asking the Food and Drug Administration (FDA) to reduce maximum storage limit for red blood cells from 6 weeks to 5 weeks, as long as there are sufficient blood supplies available. The researchers... read more
Metformin Associated with Reduced Mortality in CKD, CHF, and CLD
Metformin is currently the suggested initial treatment for type 2 diabetes mellitus in the United States. In the past, the U.S. Food and Drug Administration (FDA) did not recommend metformin for patients with chronic kidney... read more
New Warning for Anesthetic Use in Children and Pregnant Women
The FDA issued a warning that repeated or lengthy use of general anesthetics and sedatives during surgeries or procedures in children aged <3 years or in pregnant women during their 3rd trimester may affect the development... read more
Pulmaquin Looks Promising for Treating Lung Infections in Non-CF Bronchiectasis Patients
Aradigm has announced top-line results from two Phase 3 clinical trials of Pulmaquin (inhaled ciprofloxacin) for the treatment of patients with non-cystic fibrosis bronchiectasis (non-CF BE) who have chronic lung infections... read more
