HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has spa...
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 ...
CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file decision.
CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device regulatory activities.
