Ionis Pharmaceuticals reports favorable data from a Phase 1/2 open-label study of ION582 in people with Angelman syndrome.
FDA clears a Varian 510(k) for new functionality to its Ethos radiotherapy system for treating cancer.
FDA grants Tulavi Therapeutics a de novo marketing authorization for its Allay Nerve Cap, a surgical hydrogel designed to protect transected nerves to...
Federal Register notice: FDA makes available a draft guidance entitled Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.
Mainz Biomed files an application requesting a breakthrough device designation for what it calls its non-invasive next-generation colorectal cancer te...
FDA announces an 11/6 public workshop entitled Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility...
FDA awards Diamyd Medical a Fast Track designation for Diamyd (rhGAD65/alum) for use in treating Type 1 diabetes in pediatric patients with Stage 1 or...
