(Image courtesy of Medtronic) The FDA has approved the Medtronic (NYSE:MDT) MiniMed 770G hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years. The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose monitor values for for such young children, according to the agency. The FDA […]
Food & Drug Administration (FDA)
Report: Will Dr. Hahn crack under political pressure?
Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration. Hahn has been squeezed between expressing his professional […]
Tandem Diabetes Care wins expanded FDA indication for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) announced today that it won an expanded pediatric indication from the FDA for its t:slim X2 insulin pump. The t:slim X2 with Control-IQ technology won FDA clearance for controlling Type 1 diabetes in December, which was followed by a commercial launch in the U.S. the next month. Tandem touts t:slim X2 with […]
FDA clears Nanobiotix to start cancer treatment trial
Nanobiotix (PAR:NANO.PA) announced that the FDA designated its cancer treatment trial with the University of Texas MD Anderson Cancer Center as “safe to proceed.” The trial, co-developed by Nanobiotix and MD Anderson, is set to evaluate the safety and feasibility of NBTXR3 activated-by-radiation therapy for patients with locally advanced (LAPC) or borderline resectable (BRPC) cases of […]
B. Braun lands FDA EUA for use of infusion pumps with nebulizers to treat COVID-19
B. Braun Medical announced that it received FDA emergency use authorization to use its infusion pumps with nebulizers to treat patients with COVID-19. The Bethlehem, Pa.-based company’s authorization win includes its Perfusor space syringe infusion pump, Infusomat space volumetric infusion pump and Outlook ES pump systems. The pumps can be used for tracheal delivery of continuous […]
Clinical trials ramping up for potential coronavirus-fighting drugs
Bausch Health (NYSE:BHC) announced today that it initiated a clinical trial program in Canada to investigate the use of Virazole for treating COVID-19. With today’s announcement, Bausch joins Eli Lilly (NYSE:LLY) and Care Access Research, which both announced clinical testing of coronavirus therapies last week. Bausch’s Virazole is currently approved in the U.S. and Canada, among other […]
FDA approves Cipla’s generic albuterol inhaler
The FDA approved the first generic version of the Proventil HFA (albuterol sulfate) metered-dose inhaler for treating bronchospasm. The FDA indicated the generic inhaler from Cipla for the treatment or prevention of bronchospasm in patients four years of age or older with reversible obstructive airway disease. It also aids in the prevention of exercise-induced bronchospasm […]
OncoSec, Inovio testing COVID-19 vaccines
OncoSec Medical (NSDQ:ONCS) and Inovio Pharmaceuticals (NSDQ:INO) announced that they are testing potential COVID-19 vaccines after the latter received investigational new drug clearance from the FDA. Inovio received an IND nod, while OncoSec’s is pending, but both companies are pursuing a first-in-human Phase 1 clinical trial for their vaccines, according to separate news releases. OncoSec is using […]
FDA approves BioStage’s esophageal device investigational new drug application
Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was […]
Companion Medical wins FDA nod for InPen diabetes management system
Companion Medical announced that it won FDA clearance for its InPen bolus calculator for fixed dosing and meal estimation in diabetes management. The new bolus calculator is designed to account for the user’s current glucose level and active insulin to remove the guesswork from insulin dosing. Companion Medical touts the system as the first of […]
