FDA approves a Samsung Bioepis BLA for Epysqli (eculizumab-aagh) as a biosimilar to Alexions Soliris (eculizumab), indicated for treating patients wit...
New studies by FDA drug promotion staff find that consumers conflated a drugs benefits and risks when they were exposed to both a disease awareness co...
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Federal Register notice: FDA makes available a draft guidance entitled Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.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...
