The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II).

As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissioner’s National Priority Voucher pilot program.

The U.S. Food and Drug Administration today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection for weight loss and long-term maintenance of weight loss for certain adult patients.

The U.S. Food and Drug Administration today issued draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead of animal testing in drug development, and to bring safe, effective drugs to market sooner based on human-centric data.