President Trump prepares to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agreed to participate in ...
FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/or diagnosis devices...
Two bipartisan senators press FDA to take a more proactive role in policing prescription drug advertising, citing a surge in misleading direct-to-cons...
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...
