Medical Device | January 08, 2026
Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter
The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures
The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D
The company said it received notice on January 1 from the FDA’s Center for Veterinary Medicine that the funding will support its ongoing effectiveness study of Canalevia-CA1
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety
The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline
The approval is supported by data from three pivotal clinical trials
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
Subscribe To Our Newsletter & Stay Updated
