Ultragenyx Pharmaceutical refiles a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A....
In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlines an expansive agenda to accelerate drug approvals, lower costs, a...
FDA grants full approval for Kites CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell ...
A rare disease coalition calls on the Trump administration to appoint a new CBER director who understands rare disease drug development and values the...
An FDA untitled letter cautions the Fort Myers, FL-based LeeSar drug outsourcing facility about CGMP and other violations in its production of compoun...
FDA warns Clifton, NJ-based Physitemp Instruments about Quality System, Medical Device Reporting, Unapproved Device, and Unique Device Identifier viol...
A Courthouse New Service report outlines the competing arguments made before a three-judge appeals court panel in a case involving FDAs decision to re...
FDA commissioner Marty Makary says the agency is prioritizing efforts to accelerate drug development timelines beginning at the IND stage, while also ...
