FDA Panel Backs ReCor’s Renal Denervation System for Hypertension
The Paradise ultrasound renal denervation system got backing from the FDA’s Circulatory System Devices Panel as a possible treatment for hypertension, as manufacturer ReCor continues to hope for regulatory approval. On Tuesday, FDA advisors voted 10-2 that the benefits of the Paradise catheter-based system outweigh its risks when used to reduce blood pressure (BP) in […]
FDA Panel Endorses mAb to Prevent RSV in Infants
An FDA advisory committee on Thursday gave strong backing to a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease (LRTD) in infants as well as in at-risk children up to 24 months of age. In a unanimous vote, all 21 members of the Antimicrobial Drugs Advisory Committee agreed that the […]