FDA approves a UCB BLA for Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic thera...
FDA clears an Intellia Therapeutics IND to permit a Phase 3 trial of its NTLA-2001 to treat transthyretin amyloidosis with cardiomyopathy.
FDA clears a GE HealthCare 510(k) for its Allia IGS Pulse imaging system.
FDA clears a Praxis Medical 510(k) for its EndoCore EBUS-TBNA fine needle biopsy device.
After 15 years at FDA, former senior regulatory counsel Joy Sharp joins the law firm Faegre Drinker as counsel in Washington, DC.
FDA approves Mercks Keytruda (pembrolizumab) for use with platinum-containing chemotherapy as neoadjuvant treatment and continuing as a single-agent p...
Federal Register notice: FDA makes available a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.
Federal Register notice: FDA makes available a draft guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.
