Vitamin E acetate was universally found in bronchoalveolar lavage fluid samples from patients with vaping lung injury, providing the first direct evidence of vitamin E acetate at the site of injury. News Alerts
The recall stemmed from a software issue with the ROSA 3.0 system that incorrectly positions the robotic arm, potentially leading to serious injury or death, an FDA statement said. News Alerts
The Sentosa SQ HIV genotyping assay is the first HIV drug resistance assay that uses next generation sequencing technology that the FDA has authorized for use. FDA Approvals
Sanofi will transition completely from the trivalent to quadrivalent Fluzone high-dose influenza vaccines in the US. The quadrivalent vaccine will be available for the 2020-2021 flu season. FDA Approvals
Some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it, the FDA said in an updated safety alert. News Alerts
Talicia combines omeprazole, amoxicillin, and rifabutin and is designed to address growing bacterial resistance to standard clarithromycin-based H pylori therapy. FDA Approvals
Talicia combines omeprazole, amoxicillin, and rifabutin and is designed to address growing bacterial resistance to standard clarithromycin-based H pylori therapy. FDA Approvals
A calibration system error resulting from electromagnetic interference may cause the pump to slow or stop, the console screen to blank, and inaccurate alarms to sound. News Alerts
The MD Anderson Cancer Center executive is credited with restoring the giant cancer center’s financial stability. Medscape Medical News
The EMA safety committee says tofacitinib should be used with caution in all patients at high risk for blood clots. News Alerts
New recommendations are to use the drug only in cases in which the disease is highly active despite use of at least one disease-modifying agent or in cases of rapidly worsening disease. News Alerts
Diroximel fumarate showed better GI tolerability compared with dimethyl fumarate in patients with relapsing forms of multiple sclerosis in the EVOLVE-MS-2 phase 3 study. FDA Approvals
The FDA warns of potentially higher risk for type III endoleaks with two Endologix endovascular grafts that use Duraply graft material to repair of abdominal aortic aneurysm. News Alerts
After the closure of two major sterilization facilities and the potential shuttering of a third next week, device makers and federal regulators are warning of potential shortages of medical devices. Georgia Health News
Following approval in 2017 for bacteria skin infections, the fluoroquinolone antibiotic is now indicated for adults with community-acquired bacterial pneumonia. FDA Approvals
Premixed phenylephrine injection does not require compounding, reducing the risk of sterility breach, or diluting, lessening the risk of medication error; it also has a 3-year shelf life. FDA Approvals
The FDA has approved Botox to ease lower-limb spasticity in children and adolescents aged 2 to 17 years, excluding spasticity caused by cerebral palsy. FDA Approvals
In draft guidance issued today, the FDA proposes labeling changes to ensure that women receive and understand information regarding the benefits and risks of these devices. Medscape Medical News
Formulation appears in the blood approximately 2.5 minutes after dosing. Fiasp is now approved in the US for both mealtime use and continuous infusion via pump. FDA Approvals
Trikafta combines elexacaftor, ivacaftor, and tezacaftor for patients 12 years or older with CF and at least one F508del mutation in the CFTR gene. FDA Approvals
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