Alumis says envudeucitinib delivered high levels of skin clearance in two pivotal Phase 3 trials in moderate-to-severe plaque psoriasis.
FDA says a recent Dexcom 9/18/2025 software correction for its Dexcom G6 and G6 Pro continuous glucose monitoring software is Class 1.
FDA announces a 1/14 town hall to discuss its Quality Management System Regulation (QMSR) and its effective date of 2/2/2026.
FDA releases a list of 13 potential safety signals identified in drugs between 7/2025 and 9/2025.
In a PDUFA 8 reauthorization subgroup discussion, FDA and industry representatives trade data and evaluations of first-cycle reviews and debate whethe...
FDA seeks input on a new way to contract directly with venture capitalbacked innovators in an effort to possibly speed adoption of emerging technologi...
FDA posts an updated guidance outlining its processes for bioresearch monitoring inspections, which oversee the conduct, reporting, and postmarketing ...
FDA faces Increased scrutiny of its newly established Commissioners National Priority Review voucher program, which is intended to accelerate the revi...
